112 Industrial Engineering jobs in Ireland

**Job Description**
**Are You Ready to Make It Happen at Mondelēz International?**
**Join our Mission to Lead the Future of Snacking. Make It With Pride.**
You will support Mondelez Europe Quality Certification Lead in the management of Sustainability certifications schemes on a various number of sites (related to claims on packs) across Europe.
The aim is to maintain successful certification where the programs are already implemented, and to support projects of new programs implementation as needed in the future.
You will also support digitalization of some of the tasks in order to gain in efficiency.
In that role, you will have the opportunity to interact for all the Quality Community in Europe (plants & central) but also MDS (Mondelez Digital Services) and Procurement or Marketing/Sales, as well as external partners.
**How you will contribute:**
**SUSTAINABILITY CERTIFICATION PROGRAMS MANAGEMENT :**
**ORGANIC, FAIRTRADE, RAINFOREST ALLIANCE AND RSPO**
**Program coordination for existing certifications maintenance:**
Planning supervision
Communication of changes to Certification Bodies (people, process, products, sites in scope)
Information and training on Standards for new comers
Information and training on Standards changes when upgrades are published
Users set up and training on Standard specific tools (traceability, artwork approval)
Coordination of Internal audits planning for each certification scheme
Conducting some internal audits
Lead multisite external audits and support plants and central functions audits
Coordination of non conformities investigation and Action plan management
Audit invoices check and approval
Documentation maintenance on teamsite : Certificates and audit reports uploads
+ Optimization of process and procedures
&Recommendation of combination of programs for efficiency
**Support to new program implementation:**
Training on Standard for first implementation to plant(s) and central functions
Preparing certification application with required documentation for Certification Body
Support plants with documentation creation (procedures, records)
**DIGITALIZATION:**
+ Create and optimize task reminders
+ Consolidate Corrective & Preventive Action Plan trackers
+ Contribute at Mondelez Europe level to a SAP project to facilitate certification management.
+ Build learning module & learning path on certifications for other functions involved
**What you will bring**
A desire to drive your future and accelerate your career and the following experience and knowledge:
+ Related experience in operations, quality and/or R&D
+ Handling multiple tasks and prioritize
+ Communication and leadership skills on cross-functional teams
+ Business acumen and influencing and negotiating
+ Auditing certification or equivalent experience is a decided advantage
**More about this role**
**What extra ingredients you will bring:**
**Skills:**
+ SharePoint management
+ SAP QM knowledge will be a strong advantage
+ SAP PLM (nice to have)
**Education:**
+ Master Degree in Food related sciences or Food Engineering
**Languages**
+ Required : Fluent in English (orally & written) - application needs to be in English
+ Preferred : Fluent in a 3rd language (especially French)
**Certifications**
+ Qualified as Internal auditor
**Work Experience**
+ > 5 years in FMCG
+ At least 1 or 2 years in plant
+ 2 years minimum in Quality&Food Safety
+ Experience of work in cross-countries team and in remote
+ Experience in certification program management
**Skills & Competencies & Behaviors**
+ Digital Savvy. At ease with excel & numbers
+ SharePoint management
+ SAP QM knowledge will be a strong advantage + SAP PLM (nice to have)
+ Organization skills that allow for working on multiple activities concurrently
+ Communication and leadership skills on cross-functional teams
+ Business acumen and influencing and negotiating
+ Ability to deliver training in English
*** **N.B! This position is a temporary role with a mission for 18 months.**
**Relocation Support Available?**
No Relocation support available
**Business Unit Summary**
**We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!**
**_Our people make all the difference in our succes_**
Mondelēz International is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation or preference, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law.
**Excited to grow your career?**
We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is right for you, we encourage you to apply!
**IF YOU REQUIRE SUPPORT TO COMPLETE YOUR APPLICATION OR DURING THE INTERVIEW PROCESS, PLEASE CONTACT THE RECRUITER**
**Job Type**
Temporary (Fixed Term)
Corporate Quality Assurance
Product Quality, Safety and Compliance
At Mondelēz International, our purpose is to empower people to snack right through offering the right snack, for the right moment, made the right way. That means delivering a broader range of delicious, high-quality snacks that nourish life's moments, made with sustainable ingredients and packaging that consumers can feel good about.
We have a rich portfolio of strong brands - both global and local. Including many household names such as Oreo, belVita and LU biscuits; Cadbury Dairy Milk, Milka and Toblerone chocolate; Sour Patch Kids candy and Trident gum. We are proud to hold the number 1 position globally in biscuits, chocolate and candy as well as the No. 2 position in gum
Our 80,000 Makers and Bakers are located in our operations in more than 80 countries and are working to sell our products in over 150 countries around the world. They are energized for growth and critical to us living our purpose and values. We are a diverse community that can make things happen, and happen fast.
Join us and Make It An Opportunity!
Mondelez Global LLC is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, sexual orientation, gender identity, gender expression, genetic information, or any other characteristic protected by law. Applicants who require accommodation to participate in the job application process may contact for assistance.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Role
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
· Part of the Batch File Review Team who:
a. Compile batch documents
b. Review batch documents in advance of QP review
c. Work with responsible site to complete corrections
d. Prepare COC for QP
e. Work closely with QP as issues arise and find resolution
· Perform a batch file review for batches manufactured/packed at PCI or in third party company.
· Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
· Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
· Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
· Participating customer meetings - discussion/collection/summary about the necessary quality documentation
· Writing SOPs or Work Instructions
· Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
· Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential:
· Degree and/or relevant experience.
· GMP experience
· Good communication skills.
· Steriles experience is desirable.
· Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Minimum 2 yrs years' experience working in Quality Assurance
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Role
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
· Part of the Batch File Review Team who:
a. Compile batch documents
b. Review batch documents in advance of QP review
c. Work with responsible site to complete corrections
d. Prepare COC for QP
e. Work closely with QP as issues arise and find resolution
· Perform a batch file review for batches manufactured/packed at PCI or in third party company.
· Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
· Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
· Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
· Participating customer meetings - discussion/collection/summary about the necessary quality documentation
· Writing SOPs or Work Instructions
· Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
· Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential:
· Degree and/or relevant experience.
· GMP experience
· Good communication skills.
· Steriles experience is desirable.
· Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Minimum 2 yrs years' experience working in Quality Assurance
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Role
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
· Part of the Batch File Review Team who:
a. Compile batch documents
b. Review batch documents in advance of QP review
c. Work with responsible site to complete corrections
d. Prepare COC for QP
e. Work closely with QP as issues arise and find resolution
· Perform a batch file review for batches manufactured/packed at PCI or in third party company.
· Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
· Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
· Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
· Participating customer meetings - discussion/collection/summary about the necessary quality documentation
· Writing SOPs or Work Instructions
· Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
· Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential:
· Degree and/or relevant experience.
· GMP experience
· Good communication skills.
· Steriles experience is desirable.
· Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Minimum 2 yrs years' experience working in Quality Assurance
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Summary of Role
This is an exciting role as part of the Batch File Review Team. This role will appeal to anyone who enjoys a high degree of variety in their role. This role involves networking and communication across multiple stakeholders both internal and external to PCI. Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc. Ideal grounding for anyone thinking of a future career as a QP.
· Part of the Batch File Review Team who:
a. Compile batch documents
b. Review batch documents in advance of QP review
c. Work with responsible site to complete corrections
d. Prepare COC for QP
e. Work closely with QP as issues arise and find resolution
· Perform a batch file review for batches manufactured/packed at PCI or in third party company.
· Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
· Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers. Review records against approved filing/Dossier of same.
· Coordination of every product supply chain flow - products which are coming from rest of the world and releasing to the European Union
· Participating customer meetings - discussion/collection/summary about the necessary quality documentation
· Writing SOPs or Work Instructions
· Maintenance of batch documents and retain samples in archive room. Update the PQR database after QP release.
· Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
· Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills & Experience
Essential:
· Degree and/or relevant experience.
· GMP experience
· Good communication skills.
· Steriles experience is desirable.
· Ability to problem solve.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
· Minimum 2 yrs years' experience working in Quality Assurance
· Proven track record of showing how results were delivered through management/leadership of others.
· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Role Overview**
The Senior Quality Specialist will play a critical role in ensuring compliance, oversight, and continuous improvement within the Quality department. This position is accountable for supporting Qualified Person (QP) release activities through the review of third-party product documentation, managing batch records, and driving operational excellence across the Quality Management System (QMS). Acting as a key point of contact between cross-functional teams, the Senior Quality Specialist will provide leadership, technical expertise, and mentorship to the Quality team, while maintaining the highest standards of GMP compliance.
**_Main Responsibilities_** :
**Batch Review & QP Support**
+ Perform compliance reviews of third-party batch documentation, including review of technical documents and prepare batches for QP review/certification.
+ Review and maintain the Product Specification Files to ensure accuracy and compliance.
+ Manage batch review trackers, ensuring timely allocation of work across the QA team.
**Quality Systems & Compliance**
+ Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
+ Generate and report compliance metrics related to batch record review and QP preparation, ensuring continuous monitoring of QMS effectiveness.
+ Support the investigation and resolution of internal and external quality issues using risk management principles.
+ Author, review, and update SOPs, work instructions, and controlled documents.
**Cross-Functional Collaboration**
+ Partner with Project Managers, QPs, and QA colleagues to drive timely resolution of batch-related issues and corrections.
+ Collaborate effectively across departments (e.g., PMS, Operations, Regulatory) to ensure alignment and timely delivery of objectives.
+ **Inspection & Audit Support**
+ Act as SME for QA batch review during internal and external audits/inspections.
+ Support preparation, coordination, and response activities for regulatory inspections of the Millmount facility.
+ **Leadership & Team Support**
+ Provide guidance and mentorship to Quality Specialists, supporting their development and ensuring adherence to best practices.
+ Promote a culture of compliance, zero overdue actions, and Right-First-Time execution.
+ Deliver QA- and GMP-related training across the site as required.
**Continuous Improvement & Projects**
+ Support departmental and site-wide projects, initiatives, and objectives.
+ Drive continuous improvement activities to strengthen compliance, efficiency, and quality performance.
+ Undertake additional responsibilities aligned to the scope of the role.
**Requirements:**
+ Science Qualification, Degree and/or relevant experience is required
+ 2 to 3 years of sterilles experience in a manufacturing setting with good technical knowledge
+ 7+ year's QA Experience in pharmaceutical or medical device is required.
+ Clinical experience is desirable but not essential.
**Skills & Attributes:**
+ Strong attention to detail with a commitment to quality and compliance.
+ Excellent problem-solving and analytical skills.
+ Effective communication and interpersonal skills for cross-functional collaboration.
+ Leadership ability with experience guiding or mentoring others.
+ Proactive team player with a continuous improvement mindset.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Role Overview**
The Senior Quality Specialist will play a critical role in ensuring compliance, oversight, and continuous improvement within the Quality department. This position is accountable for supporting Qualified Person (QP) release activities through the review of third-party product documentation, managing batch records, and driving operational excellence across the Quality Management System (QMS). Acting as a key point of contact between cross-functional teams, the Senior Quality Specialist will provide leadership, technical expertise, and mentorship to the Quality team, while maintaining the highest standards of GMP compliance.
**_Main Responsibilities_** :
**Batch Review & QP Support**
+ Perform compliance reviews of third-party batch documentation, including review of technical documents and prepare batches for QP review/certification.
+ Review and maintain the Product Specification Files to ensure accuracy and compliance.
+ Manage batch review trackers, ensuring timely allocation of work across the QA team.
**Quality Systems & Compliance**
+ Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
+ Generate and report compliance metrics related to batch record review and QP preparation, ensuring continuous monitoring of QMS effectiveness.
+ Support the investigation and resolution of internal and external quality issues using risk management principles.
+ Author, review, and update SOPs, work instructions, and controlled documents.
**Cross-Functional Collaboration**
+ Partner with Project Managers, QPs, and QA colleagues to drive timely resolution of batch-related issues and corrections.
+ Collaborate effectively across departments (e.g., PMS, Operations, Regulatory) to ensure alignment and timely delivery of objectives.
+ **Inspection & Audit Support**
+ Act as SME for QA batch review during internal and external audits/inspections.
+ Support preparation, coordination, and response activities for regulatory inspections of the Millmount facility.
+ **Leadership & Team Support**
+ Provide guidance and mentorship to Quality Specialists, supporting their development and ensuring adherence to best practices.
+ Promote a culture of compliance, zero overdue actions, and Right-First-Time execution.
+ Deliver QA- and GMP-related training across the site as required.
**Continuous Improvement & Projects**
+ Support departmental and site-wide projects, initiatives, and objectives.
+ Drive continuous improvement activities to strengthen compliance, efficiency, and quality performance.
+ Undertake additional responsibilities aligned to the scope of the role.
**Requirements:**
+ Science Qualification, Degree and/or relevant experience is required
+ 2 to 3 years of sterilles experience in a manufacturing setting with good technical knowledge
+ 7+ year's QA Experience in pharmaceutical or medical device is required.
+ Clinical experience is desirable but not essential.
**Skills & Attributes:**
+ Strong attention to detail with a commitment to quality and compliance.
+ Excellent problem-solving and analytical skills.
+ Effective communication and interpersonal skills for cross-functional collaboration.
+ Leadership ability with experience guiding or mentoring others.
+ Proactive team player with a continuous improvement mindset.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Role Overview**
The Senior Quality Specialist will play a critical role in ensuring compliance, oversight, and continuous improvement within the Quality department. This position is accountable for supporting Qualified Person (QP) release activities through the review of third-party product documentation, managing batch records, and driving operational excellence across the Quality Management System (QMS). Acting as a key point of contact between cross-functional teams, the Senior Quality Specialist will provide leadership, technical expertise, and mentorship to the Quality team, while maintaining the highest standards of GMP compliance.
**_Main Responsibilities_** :
**Batch Review & QP Support**
+ Perform compliance reviews of third-party batch documentation, including review of technical documents and prepare batches for QP review/certification.
+ Review and maintain the Product Specification Files to ensure accuracy and compliance.
+ Manage batch review trackers, ensuring timely allocation of work across the QA team.
**Quality Systems & Compliance**
+ Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
+ Generate and report compliance metrics related to batch record review and QP preparation, ensuring continuous monitoring of QMS effectiveness.
+ Support the investigation and resolution of internal and external quality issues using risk management principles.
+ Author, review, and update SOPs, work instructions, and controlled documents.
**Cross-Functional Collaboration**
+ Partner with Project Managers, QPs, and QA colleagues to drive timely resolution of batch-related issues and corrections.
+ Collaborate effectively across departments (e.g., PMS, Operations, Regulatory) to ensure alignment and timely delivery of objectives.
+ **Inspection & Audit Support**
+ Act as SME for QA batch review during internal and external audits/inspections.
+ Support preparation, coordination, and response activities for regulatory inspections of the Millmount facility.
+ **Leadership & Team Support**
+ Provide guidance and mentorship to Quality Specialists, supporting their development and ensuring adherence to best practices.
+ Promote a culture of compliance, zero overdue actions, and Right-First-Time execution.
+ Deliver QA- and GMP-related training across the site as required.
**Continuous Improvement & Projects**
+ Support departmental and site-wide projects, initiatives, and objectives.
+ Drive continuous improvement activities to strengthen compliance, efficiency, and quality performance.
+ Undertake additional responsibilities aligned to the scope of the role.
**Requirements:**
+ Science Qualification, Degree and/or relevant experience is required
+ 2 to 3 years of sterilles experience in a manufacturing setting with good technical knowledge
+ 7+ year's QA Experience in pharmaceutical or medical device is required.
+ Clinical experience is desirable but not essential.
**Skills & Attributes:**
+ Strong attention to detail with a commitment to quality and compliance.
+ Excellent problem-solving and analytical skills.
+ Effective communication and interpersonal skills for cross-functional collaboration.
+ Leadership ability with experience guiding or mentoring others.
+ Proactive team player with a continuous improvement mindset.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
**We are PCI.**
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
**Role Overview**
The Senior Quality Specialist will play a critical role in ensuring compliance, oversight, and continuous improvement within the Quality department. This position is accountable for supporting Qualified Person (QP) release activities through the review of third-party product documentation, managing batch records, and driving operational excellence across the Quality Management System (QMS). Acting as a key point of contact between cross-functional teams, the Senior Quality Specialist will provide leadership, technical expertise, and mentorship to the Quality team, while maintaining the highest standards of GMP compliance.
**_Main Responsibilities_** :
**Batch Review & QP Support**
+ Perform compliance reviews of third-party batch documentation, including review of technical documents and prepare batches for QP review/certification.
+ Review and maintain the Product Specification Files to ensure accuracy and compliance.
+ Manage batch review trackers, ensuring timely allocation of work across the QA team.
**Quality Systems & Compliance**
+ Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
+ Generate and report compliance metrics related to batch record review and QP preparation, ensuring continuous monitoring of QMS effectiveness.
+ Support the investigation and resolution of internal and external quality issues using risk management principles.
+ Author, review, and update SOPs, work instructions, and controlled documents.
**Cross-Functional Collaboration**
+ Partner with Project Managers, QPs, and QA colleagues to drive timely resolution of batch-related issues and corrections.
+ Collaborate effectively across departments (e.g., PMS, Operations, Regulatory) to ensure alignment and timely delivery of objectives.
+ **Inspection & Audit Support**
+ Act as SME for QA batch review during internal and external audits/inspections.
+ Support preparation, coordination, and response activities for regulatory inspections of the Millmount facility.
+ **Leadership & Team Support**
+ Provide guidance and mentorship to Quality Specialists, supporting their development and ensuring adherence to best practices.
+ Promote a culture of compliance, zero overdue actions, and Right-First-Time execution.
+ Deliver QA- and GMP-related training across the site as required.
**Continuous Improvement & Projects**
+ Support departmental and site-wide projects, initiatives, and objectives.
+ Drive continuous improvement activities to strengthen compliance, efficiency, and quality performance.
+ Undertake additional responsibilities aligned to the scope of the role.
**Requirements:**
+ Science Qualification, Degree and/or relevant experience is required
+ 2 to 3 years of sterilles experience in a manufacturing setting with good technical knowledge
+ 7+ year's QA Experience in pharmaceutical or medical device is required.
+ Clinical experience is desirable but not essential.
**Skills & Attributes:**
+ Strong attention to detail with a commitment to quality and compliance.
+ Excellent problem-solving and analytical skills.
+ Effective communication and interpersonal skills for cross-functional collaboration.
+ Leadership ability with experience guiding or mentoring others.
+ Proactive team player with a continuous improvement mindset.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( Employment Opportunity (EEO) Statement:**
_PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._
_At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled