Senior Quality Assurance Specialist
3 weeks ago
At PCI Pharma Services, we are committed to delivering life-changing therapies to patients around the world. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our manufacturing processes.
Main Responsibilities:
- Review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation.
- Review Batch Documents for all operations performed at PCI Pharma Services.
- Certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).
- Undertake audits in the UK, EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP.
- Provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
- Keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of world (where relevant).
- Review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
- Provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.
- Assistance with regulatory inspections and client audits.
- Perform Supply Chain Oversight when required.
Requirements:
- Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with UK legislation and EU directives 2001/83/EC and 2001/20/EC respectively.
- Experience working as a QP in the certification of sterile medicinal products in particular Biopharmaceuticals manufactured aseptically.
- Extensive QA experience within the medicinal products/pharmaceutical industry.
- GMP Audit experience preferably qualified as Lead Auditor.
- Experience in Biopharmaceuticals.
- Experience in Sterile manufacture.
- Effective Communication skills.
- Good IT skills (at least MS Word).
We are PCI Pharma Services, and we are committed to building the bridge between life-changing therapies and patients.
-
Quality Assurance Specialist
3 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeAt PCI Pharma Services, we are committed to delivering life-changing therapies to patients worldwide. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products.Main Responsibilities:Conduct quality control inspections for incoming materials, works order checks, master label proofs, label checks,...
-
Quality Assurance Specialist
1 day ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at PCI Pharma Services.Company OverviewPCI Pharma Services is a leading global contract development and manufacturing organization (CDMO) that provides comprehensive solutions for pharmaceutical and biotechnology companies.Job DescriptionThis role will be responsible for...
-
Senior Quality Assurance Specialist
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeJob DescriptionWe are seeking a highly skilled and experienced Senior Quality Assurance Specialist to join our team at PCI Pharma Services.The successful candidate will be responsible for reviewing Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation.Main Responsibilities:To review...
-
Quality Assurance Specialist
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full timeQuality Controller OpportunityFMG Repair Services is seeking a skilled Quality Controller to join our team at our busy workshop in Bridgend. As a Quality Controller, you will be responsible for reviewing and signing off on the full rectification and repair of vehicles to manufacturer and company standards.Key Responsibilities:Review and sign off on vehicle...
-
Senior Financial Analyst
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom Hays Senior Finance Full timeJob Opportunity: Financial Reporting SpecialistHays Senior Finance is seeking a highly skilled Financial Reporting Specialist to join our team. As a key member of our finance department, you will be responsible for supporting projects and process improvement across the business.Key Responsibilities:Supporting projects and process improvement across the...
-
Quality Control Specialist
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeAt PCI Pharma Services, we are committed to delivering high-quality products and services to our customers. As a Quality Control Specialist, you will play a critical role in ensuring the quality of our products and processes.Main Responsibilities:Conduct quality control inspections of incoming materials, works order checks, master label proofs, label checks,...
-
Senior Quality Assurance Manager
1 week ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeWe are PCI, a global company making a difference in people's lives by connecting life-changing therapies with patients.Our mission is to build a team that drives progress and creates a better tomorrow.We are seeking a talented Senior Quality Control Inspector to join our team and help us achieve our objectives.Key responsibilities:Supervise QC Inspectors to...
-
Senior Quality Control Specialist
7 days ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeJob DescriptionAt PCI Pharma Services, we are committed to bridging the gap between life-changing therapies and patients. As a Senior Quality Control Specialist, you will play a vital role in ensuring the quality of our products and processes.Main Responsibilities:Conduct QC inspection processes for Incoming materials, Works order checks (IPCs), Master label...
-
Quality Control Specialist
3 days ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeJob DescriptionAt PCI Pharma Services, we are committed to delivering life-changing therapies to patients around the world.We are seeking a highly skilled Quality Control Specialist to join our team in Pharmaceutical Quality Assurance. As a key member of our Operations department, you will play a crucial role in ensuring the quality and integrity of our...
-
Senior Quality Assurance Specialist
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeLife-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI Pharma Services.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.General Purpose of Role:To certify...
-
Senior Quality Assurance Specialist
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeLife Changing Therapies. Global Impact.At PCI Pharma Services, we are committed to building a bridge between life-changing therapies and patients. Our investment is in people who make an impact, drive progress, and create a better tomorrow.Main Responsibilities:To review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product...
-
Senior Quality Assurance Manager
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeTransforming lives through groundbreaking therapies and global impact.PCI Pharma ServicesWe invest in people who drive progress, create a better tomorrow, and pioneer the future of our industry.To lead our Quality Control Inspectors in meeting operational requirements and company objectives.Key Responsibilities:Organize QC Inspectors to ensure core QC...
-
Senior Quality Assurance Manager
3 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeTransforming lives through innovative therapies and global impact.PCI Pharma ServicesWe invest in people who drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of quality control.To supervise the QC Inspectors and ensure operational requirements and company objectives...
-
Senior Financial Analyst
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom Hays Senior Finance Full timeJob Opportunity: Senior Financial AnalystAt Hays Senior Finance, we are seeking a highly skilled Senior Financial Analyst to join our team. As a Senior Financial Analyst, you will be responsible for supporting projects and process improvement across the business.Key Responsibilities:Supporting projects and process improvement across the business.Assisting...
-
Senior Financial Analyst
3 weeks ago
Bridgend, Bridgend county borough, United Kingdom Hays Senior Finance Full timeJob SummaryWe are seeking a highly skilled Senior Financial Analyst to join our team at Hays Senior Finance. As a Senior Financial Analyst, you will be responsible for supporting projects and process improvement across the business, assisting with month-end closing processes, and preparing and analyzing financial reports.Key ResponsibilitiesSupporting...
-
Senior Quality Assurance Manager
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeLife-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI Pharma Services.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.To supervise the QC Inspectors to...
-
Senior Quality Assurance Manager
3 weeks ago
Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full timeTransforming lives through innovative therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI Pharma Services.Our investment is in people who make a difference, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.To...
-
Financial Reporting Specialist
3 weeks ago
Bridgend, Bridgend county borough, United Kingdom Hays Senior Finance Full timeJob SummaryWe are seeking a highly skilled Financial Reporting Specialist to join our team in Bridgend. As a key member of our finance department, you will be responsible for supporting projects and process improvement across the business.Key ResponsibilitiesSupporting projects and process improvement across the business.Assisting and covering month end...
-
Senior Project Specialist
2 weeks ago
Bridgend, Bridgend county borough, United Kingdom Morwell Talent Solutions Full time £65,000Job Title: Senior Project SpecialistAbout the Role:We are seeking a qualified Senior Project Specialist to join our team at Morwell Talent Solutions. As a Senior Project Specialist, you will be responsible for leading and managing the finance function, ensuring the day-to-day financial activities of the company run smoothly.Key Responsibilities:Lead and...
-
Senior Nurse Specialist
4 weeks ago
Bridgend, Bridgend county borough, United Kingdom Cwm Taf Morgannwg University Health Board Full timeThe role of the Senior Nurse Specialist involves providing high-quality patient care in a secure setting. The successful candidate will be responsible for coordinating care needs, delegating tasks to junior staff, and supporting their professional development.Main ResponsibilitiesProvide expert generalist care to patients in a primary care setting.Work...