58 Quality Specialist jobs in Ireland

Process Improvement Project Engineer

Dublin, Leinster Sanderson Recruitment (Ireland) Limited

Posted 10 days ago

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Job Description

Process Improvement Project Engineer Job Purpose: Reporting to the CEO you will be designing, developing, & optimising manufacturing processes to unlock capacity, eliminate bottlenecks, & enhance operational efficiency. You will drive scalable growth while maintaining the highest standards of product quality, safety, & compliance, identifying barriers to growth, recommending improvements, & leading strategic process optimisation initiatives. Key Responsibilities you will: - Process Documentation & Barrier Identification Lead the effort to document barriers to growth & operational inefficiencies within current production lines. Develop detailed process maps & identify areas for improvement, collaborating with cross-functional teams to implement solutions. Recommend future capital investment needs based on identified process constraints & opportunities for growth. Process Design To work closely with the R&D & Engineering teams to design sustainable aligned with future business needs. Lead all other initiatives to grow manuf. capability inc. the design & dev. of new manuf. facilities to support business scalability. Process Optimisation & Capacity Mgt. Conduct in-depth analysis of current production processes to identify capacity constraints, inefficiencies, across all technologies. Develop & implement strategies to resolve capacity issues, improve throughput, reduce batch fails & maximise yields & production output. Work closely with the operations team to optimize resource allocation & production scheduling & reduce downtime Lead initiatives to enhance plant capacity utilisation through process re-engineering & Lean Manufacturing principles. Continuous Improvement Promote & drive the company's continuous improvement programme using Lean/Six Sigma methodologies & principles. Design & implement process improvements that enhance product quality, reduce waste, & optimise yield. Monitor & report on (KPIs) to track the impact of improvements & ensure alignment with company goals Project Mgt. Lead process improvement projects from initiation through to implementation, ensuring projects are completed on time, within budget, & with minimal disruption to production. Develop & manage project timelines, resources, & budgets, ensuring effective execution of process optimisation initiatives. Collaboration & Stakeholder Mgt. Collaborate with operations, engineering, maintenance, S&T & R&D teams to ensure alignment in achieving operational goals & implementing process improvements. Effectively communicate process changes, new methodologies, & best practices effectively to all levels of staff. Work with the Senior Leadership Team to align process improvement strategies with broader business objectives. Training & Development - support the training & dev of operations staff on new processes, equipment, & operational procedures. CapEx - Lead all other initiatives to exp&/unlock manuf. capability inc. the location & design of a new manufacturing facility. Demonstrate financial discipline & compliance to overall Capex policy. Skills & Qualifications / Experience you will bring: - 3-5 years in process Eng or Operations management within manufacturing ideally in the food industry. BSc/BA in a Business project management or engineering related discipline. Exp. with automation tech, digital manufacturing, data-driven process optimisation Strong operational, commercial awareness, sound judgment & decision-making capability. Expertise in process mapping, root cause analysis, & process reengineering. In-depth knowledge of statutory & regulatory requirements of Food Safety, Customer Codes of Practice, H&S, & Env. Compliance. Can implement Lean Manuf. principles & CI methodologies. Strong problem-solving ability for mech & process-related challenges, addressing root causes. Exceptional stakeholder mgt. skills, inc. exp. work with employees, customers, auditors, & vendors/contractors. Proven negotiation & influencing skills in complex operational environments Excellent communication skills (both verbal & written) sharing technical concepts easily . Collating, analysing, & presenting data to support strategic decision-making. Challenge status quo & drive meaningful change in a constructive & professional manner. Strong business acumen with a proactive & strategic mindset. Enthusiastic, energetic, & optimistic with a can-do attitude. Working 4 days on site and 1 from home. The Benefits include: Commensurate salary negotiable Laptop, phone, P-card; Daytime role (M to F) 08:30 - 17:30 and at least four days on site. Skills: project engineering NPI food production process improvement
This advertiser has chosen not to accept applicants from your region.

Senior Quality Assurance Specialist

Athlone, Leinster Morgan McKinley

Posted 1 day ago

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Job Description

Senior Quality Assurance Associate Our client is a GMP-certified pharmaceutical site based in Athlone, specialising in innovative, plant-based active pharmaceutical ingredients, including products with controlled drug status. The Opportunity: This is a rare chance for an experienced Quality Assurance professional to step into a high-impact, senior-level position at a new, tightly regulated GMP site. As Senior QA Associate, you will play a pivotal role in building, embedding, and evolving the site's quality systems, culture, and operational excellence. Reporting to the Director of Quality, you'll have real influence across all aspects of site QA - from audits, change control and deviations, to training, risk management, validation, and cross-functional collaboration. Key Responsibilities: Support the design and ongoing improvement of the QMS in line with GMP and HPRA expectations. Manage change control, document control, CAPAs, and deviations, ensuring robust root cause analysis and effectiveness checks. Ensure data integrity, traceability, and compliance across all quality records. Act as QA lead during internal/external audits (HPRA, customer, etc.). Lead site-wide risk assessments (ICH Q9), and implement risk-reducing improvements. Deliver and track GMP training, mentor junior QA staff and cross-functional teams. Champion a culture of continuous quality improvement. Requirements: Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or similar. 5+ years' experience in GMP QA, ideally in API or pharmaceutical manufacturing. Strong working knowledge of GMP, HPRA regulations, quality systems, CAPA/deviation handling, and training. Skills: QA Quality Pharmaceuticals
This advertiser has chosen not to accept applicants from your region.

Senior Quality Assurance Specialist

Cork, Munster Morgan McKinley

Posted 1 day ago

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Job Description

Senior Quality Assurance Specialist Location: Cork Industry: Pharmaceutical Employment Type: Full-Time Our client, a leading global pharmaceutical organization, is seeking a Senior Quality Assurance (QA) Specialist to join their dynamic team. This is a fantastic opportunity for an experienced QA professional to work in a high-impact, compliance-driven environment and play a pivotal role in ensuring product quality throughout the lifecycle. Key Responsibilities: Ensure full cGMP compliance in all project- and product-related activities and systems. Develop and implement quality policies, procedures, and continuous improvement initiatives. Support supplier qualification processes and collaborate closely with Procurement and external partners to ensure quality standards are met. Lead and manage all quality aspects of assigned projects and products, ensuring compliance with regulatory and internal standards. Oversee a broad range of QA-related areas such as: -Raw materials, supplier management, production processes -Specifications, change control, deviations, CAPA -Batch release, cleaning validation, audits, and customer complaints -Quality documentation, stability programs, regulatory compliance Provide quality support for the introduction of new products, including document review and approval. Ensure that all activities comply with Health, Safety, and Environmental standards. Be present on the manufacturing floor to offer real-time support and oversight. Qualifications & Experience: Bachelor's degree (or equivalent) in Pharmaceutical Sciences, Chemistry, Chemical Engineering 5 years of QA experience in a GMP-regulated pharmaceutical environment - mandatory Hands-on experience in a GMP operational setting Strong knowledge of GMP standards and regulatory requirements
This advertiser has chosen not to accept applicants from your region.

Quality Systems Specialist

Dundalk, Leinster PCI Pharma Services

Posted 4 days ago

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Job Description

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**
The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#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
This advertiser has chosen not to accept applicants from your region.

Quality Systems Specialist

Drogheda, Leinster PCI Pharma Services

Posted 4 days ago

Job Viewed

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Job Description

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**
The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#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
This advertiser has chosen not to accept applicants from your region.

Quality Systems Specialist

PCI Pharma Services

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

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**
The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#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
This advertiser has chosen not to accept applicants from your region.

Quality Systems Specialist

PCI Pharma Services

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

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**
The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#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
This advertiser has chosen not to accept applicants from your region.
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Quality Systems Specialist

Blanchardstown, Leinster PCI Pharma Services

Posted 4 days ago

Job Viewed

Tap Again To Close

Job Description

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**
The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.
**Key Responsibilities**
+ Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
+ Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
+ Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
+ Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
+ Prepare Quarterly reports for each site.
+ Prepare Product Quality Review reports.
+ Prepare & present Monthly/Annual Metrics.
+ Complete complaints investigations and assist with close out of complaints.
+ Perform cGMP internal audits.
+ Assist in the performance of external audits (as required).
+ Responsible for executing training for quality & other relevant persons.
+ Assist with preparation for customer/regulatory audits.
+ Assist with audit requests during customer/regulatory audits.
+ Prepare responses to customer audits.
+ Host/attend cross departmental meetings as required as quality representation.
+ Identify and support opportunities for improving processes and or procedures.
+ To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder's capabilities.
+ 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:**
+ Bachelor's or associate degree or Diploma / Certificate in GMP, Regulatory and Compliance or similar. May substitute experience in lieu of educational requirements.
+ 1+ years' experience working in GMP or Regulated Environment
+ Ability to manage multiple tasks and set priorities.
+ Problem Solving and Troubleshooting skills. The successful candidate should display a dynamic and proactive approach to manage problems.
+ Self-motivated with a results driven approach.
+ Adaptable and ability to work collaboratively.
+ Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
+ Driving Licence Required.
**Desirable:**
+ Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements.
#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
This advertiser has chosen not to accept applicants from your region.

Quality Systems Specialist

Ballina, Connacht LGC Limited

Posted 1 day ago

Job Viewed

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Job Description

Job Description What you'll be doing You'll lead and support a broad range of quality systems activities, including: Implementing, maintaining, and improving our Quality Management System (QMS) Maintaining relationships with Economic Operators (Suppliers, Distributors, Importers, and Authorised Representatives) Reviewing and approving new Economic Operators in collaboration with Purchasing and Business Development teams Developing quality agreements with Economic Operators alongside Purchasing and Legal Monitoring supplier performance and supporting investigations of non-conforming materials (e.g., SCARs) Leading internal and supplier audits as the site Lead Auditor Supporting Incoming Quality Assurance - raw material specifications, CoA reviews, and visual inspections Participating in external audits (HPRA, Notified Body, Customer) Contributing to NCs, CAPAs, Change Controls, and Document Control Reviewing and approving SOPs, manufacturing documentation, and material control records Maintaining strong housekeeping and compliance with Health & Safety policies Qualifications B.Sc. in Science, Engineering, QA, or a related field Lead Auditor qualification Minimum 2 years' experience in a quality role, ideally within diagnostics or regulated manufacturing Solid understanding of regulatory standards: FDA 21 CFR 820, ISO 13485, IVDD 98/79/EC, IVDR (EU) 2017/746 Familiarity with ISO 14971 (Risk Management) Additional Information What's in it for you? 25 days annual leave Health allowance and life assurance Retail discounts (local and national) 24/7 Employee Assistance Programme Recognition & reward schemes Ongoing career development & progression opportunities A supportive culture driven by our values: Passion | curiosity | integrity | brilliance | respect At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know. #lgcij To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register.
This advertiser has chosen not to accept applicants from your region.

Director, Business Performance and Process Improvement

Dublin, Leinster UnitedHealth Group

Posted 24 days ago

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Job Description

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start **Caring. Connecting. Growing together.**
**About the Role**
We are looking for a dynamic, inspiring, and strategic Transformation Leader to steer our organization through a period of significant change and growth. The ideal candidate will be a charismatic individual who not only envisions the future of our organization but also possesses the ability to motivate and lead our team toward that future. We have a key leadership role open for the Director Business Performance & Process Improvement; Payment Integrity based in Ireland.
_Careers with Optum offer flexible work arrangements and individuals who live and work in the Republic of Ireland will have the opportunity to split their monthly work hours between our Dublin and Letterkenny offices and telecommuting from a home-based office._
**Primary Responsibilities:**
Responsible for the identification of process improvements to support affordability savings through:
+ Develop Clinical Business Performance Improvement Strategy across Optum Health value streams to support an ambitious growth target of medical cost savings
+ Lead on implementing continuous improvements or strategic improvements to lead PI portfolio for Optum Health and support Gross Medical Cost Savings of approximately $ 3 Billion
+ Leadership and strategic planning skills to drive strategic operating model of the business keeping in mind the growth/innovation pillars to support the business
+ Develop and articulate Behavioral Health Payment Integrity Business Process Improvement & Transformation Strategy aligning it with our core values and business goals
+ Lead and inspire a culture of innovation, continuous improvement, and adaptability across all levels of the organization to support an ambitious growth target and medical cost savings
+ Strategize & lead Transformation roadmap to achieve multi year benefits in collaboration with Product, Technology, analytics & Automation leaders
+ Drive organizational change initiatives, ensuring they are strategically aligned, effectively communicated, and successfully implemented
+ Create a high performing process exceeding all KPIs, & SLAs in partnership with Operations, Analytics and automation
+ Ensure operational performance improvements are tracked accurately, by establishing and automating statistical control models for value streams, utilizing internal tools and processes
+ Drive changes to performance metrics in partnership with finance, Analytics, workforce management / industrial engineering and ensuring benefits are accounted in P&L accurately
+ Communicate with Leadership/Senior Leadership about progress, challenges and actions required to remove hurdles
+ Provide guidance and assistance to internal and external (client) partners to ensure programs and strategies are implemented effectively and value realized
+ Collaborate with stakeholders, ability to influence without authority to gain support and buy-in for proposed business process solutions and adherence to team requirements
+ Stay up-to-date with industry trends, emerging technologies, and best practices in business transformation
**Required Qualifications**
+ Bachelor's Degree or Undergraduate degree with equivalent experience in Business Operations, Transformation, Change Management and Strategy
+ Demonstrated ability to develop and implement successful organizational change initiatives
+ Exceptional communication and interpersonal abilities, with the skill to inspire and motivate teams
+ A track record of fostering an inclusive and collaborative work environment
+ Prove track record in managing large scale complex programs within a matrix environment
+ Trained in process improvement and change management programs like Six Sigma, Lean or equivalent degree from reputed university
+ Working knowledge of US health care and payment integrity in specific
**Preferred Qualifications**
+ Six Sigma Black Belt certified with in-depth understanding of LEAN process
+ Knowledge / understanding of CPC coding
**Careers with Optum.** Here's the idea. We built an entire organization around one giant objective; make the health system work better for everyone. So when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.SM
_At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission._
_Diversity creates a healthier atmosphere: Optum is an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to gender, civil status, family status, sexual orientation, disability, religion, age, race, and membership of the Traveller community, or any other characteristic protected by law. Optum is a drug-free workplace. © 2024 Optum Services (Ireland) Limited. All rights reserved._
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