124 Jobs in Drogheda

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:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
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:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
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:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
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:**
**Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.**
**Responsibilities:**
**Ensure that all product produced conforms to the approved specification.**
**All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.**
**Sampling tests are carried out at the required frequency.**
**Visual inspections are carried out at required frequencies.**
**Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.**
**Approval of area / line clearances and pre-production samples as required as per defined procedures.**
**QC samples are collected as per the batch packaging record.**
**Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.**
**Deviations are reported to the immediate supervisor.**
**Yields are being monitored versus goals & timely corrective actions are being taken.**
**Machine downtime is being actioned in a timely fashion.**
**Achieve the desired level of competency as per the relevant training plan.**
**Ensure that all batch packaging records are completed accurately in a timely manner.**
**Ensure that quantities of good & rejects are accurately recorded.**
**Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.**
**Work positively with all Team Leaders, Engineers and Packaging Manager at all times.**
**Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.**
**This role demands flexibility to changes in shift patterns at short notice.**
**Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.**
**Assist in all technical aspects and projects as and when required by the Packaging Manager.**
**Knowledge / Skills & Experience**
**Essential:**
**Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.**
**Fluent English**
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:**
Responsible, in conjunction with the immediate supervisor for shift output, quality and yield in compliance with the requirements of current Good Manufacturing Practice.
**Responsibilities:**
+ Ensure that all product produced conforms to the approved specification.
+ All materials required for the batch are booked in and documented accurately and conform to the packaging instruction & batch packaging record.
+ Sampling tests are carried out at the required frequency.
+ Visual inspections are carried out at required frequencies.
+ Liaise with the QA dept. for support in area / line clearances along with any other specific quality issues which may arise during production.
+ Approval of area / line clearances and pre-production samples as required as per defined procedures.
+ QC samples are collected as per the batch packaging record.
+ Ensure consistent adherence to operating, quality and machine cleaning and safety procedures in production.
+ Deviations are reported to the immediate supervisor.
+ Yields are being monitored versus goals & timely corrective actions are being taken.
+ Machine downtime is being actioned in a timely fashion.
+ Achieve the desired level of competency as per the relevant training plan.
+ Ensure that all batch packaging records are completed accurately in a timely manner.
+ Ensure that quantities of good & rejects are accurately recorded.
+ Ensure excellence in Housekeeping and that cleaning logbooks, LUMAC logs and other production-floor logs are completed and kept up to date.
+ Work positively with all Team Leaders, Engineers and Packaging Manager at all times.
+ Ensure safe work practices are being followed at all times and report any defects immediately to the Safety Officer / Packaging Manager.
+ This role demands flexibility to changes in shift patterns at short notice.
+ Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
+ Assist in all technical aspects and projects as and when required by the Packaging Manager.
**Knowledge / Skills & Experience**
**Essential:**
+ Capability to meet clear goals, communicate clearly and ensure progress to completion meeting predefined targets.
+ Fluent English
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.
We are now looking for a **Maintenance Technician** (Permanent role) to join our team in Dundalk, County Louth.
This is a **Night Shift** role, covering Monday to Wednesday 12 hours shift (7pm to 7am).
**Profile:**
Hands on engineer with ability to maximize machine reliability and throughput while supporting new projects.
A self-starter with initiative to drive the team forward in a co-operative yet assertive manner.
Ability to synthesise information from various sources and analyse and decide on a course of action.
**Primary Responsibilities:**
+ Maximise the efficiency of engineering personnel and equipment.
+ Directly responsible for acting on machines to ensure that yield and cycle time targets are met.
+ Execute job cards and ensure sufficient close out of the jobs.
+ Ensure preventive maintenance system is maintained and work complete in time.
+ Liaise with Production supervisor on resolution of technical issues.
+ Responsible for Installation and Setup of Tooling and Camera Systems. Monitoring and ensuring daily adherence to Standard Operating Conditions / Validated Parameters on all equipment In Production.
+ Assist Quality / Engineering / Project Introduction with 'new material / systems / projects or trials in production when required. - scoping, defining and implementation of mechanical and electrical modifications.
+ Assist in development and training of other Technicians, Machine setters and Operators in their roles.
+ Management of booking out spares.
+ Ensure safe work practices are being always followed- support H&S representative.
+ Ensure close out of "see cards".
+ LOTO procedure is adhered to.
+ Ensure that all activities are following the requirements of Good Manufacturing Practice.
+ Ensure excellence in Housekeeping and the cleaning schedule is adhered to.
+ Ensure close out of CAPA's, Deviations and memos.
+ Work in conjunction with other departments, QA, Production, logistics etc. to improve performance of company.
+ Carry out various other additional tasks that may be required by the Engineering Manager.
**Essential:**
+ Craft / trade fault finding electrician or mechanical certificate.
**Desirable:**
+ GMP / Pharma / Packaging experience.
#LI-VR1
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.
**Purpose of the Role**
The Operations Manager is responsible for the day-to-day management of warehouse and production operations, ensuring seamless coordination, compliance, and performance across both functions. This role will lead, support, and develop the Warehouse and Production Supervisors to meet operational targets, ensure inspection readiness, and drive a culture of continuous improvement, safety, and collaboration.
The Operations Manager will act as a key link between the Operations Director and front-line supervisors to translate business objectives into clear operational deliverables.
**Key Responsibilities**
+ Provide leadership, direction, and coaching to Warehouse and Production Supervisors.
+ Monitor daily performance across warehouse and production functions to ensure alignment with planning, quality, and safety targets.
+ Drive accountability for achieving KPIs, including output, inventory accuracy, compliance, and delivery performance.
+ Lead daily tiered meetings to ensure communication, issue resolution, and operational alignment.
+ Ensure both production and warehouse activities meet GMP, GDP, Health & Safety, and regulatory standards.
+ Support audit readiness across functions; participate in inspections and own closure of cross-functional CAPAs where applicable.
+ Champion adherence to SOPs, batch documentation standards, and good documentation practices.
+ Collaborate with Planning, QA, and Supply Chain to ensure seamless flow of materials and timely completion of production plans.
+ Monitor and mitigate risks that may impact schedule adherence or material availability.
+ Identify and lead cross-functional improvement initiatives focused on productivity, cost-efficiency, safety, and quality.
+ Support root cause analysis, lead investigations when required, and ensure effective implementation of corrective actions.
+ Develop and maintain multiskilled and flexible teams through structured cross-training programs.
+ Conduct performance reviews, coaching, and development planning for direct reports.
+ Foster a positive, safety-first culture that encourages engagement and accountability.
+ Provide timely updates to the Operations Director on operational performance, risks, and improvement plans.
+ Ensure escalation procedures are followed effectively and that decision-making is data-driven and prompt.
**Qualifications**
+ Bachelor's Degree, Diploma, or Certificate in logistics, supply chain, or related field (or equivalent experience).
+ Evidence of Continuous Professional Development.
**Key Requirements**
+ Minimum 5 years of experience in operations leadership within a GMP-regulated manufacturing or logistics environment.
+ Strong knowledge of production and warehousing workflows, regulatory compliance, and EHS practices.
+ Proven ability to manage, develop, and lead cross-functional teams.
+ Demonstrated experience in continuous improvement, problem-solving, and performance management.
+ Excellent communication, planning, and organisational skills.
+ Proficiency in ERP systems (e.g., JDE) and lean manufacturing tools preferred
#LI-MS1
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.
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:Compile batch documentsReview batch documents in advance of QP reviewWork with responsible site to complete correctionsPrepare COC for QPWork 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
+ Steriles Experience
+ Good communication skills.
+ 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