Senior Quality Assurance Specialist

1 week ago

Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

Job Description

We 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 Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation.
  • To review Batch Documents for all operations performed at PCI Pharma Services.
  • To certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).
  • To 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.
  • To provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.
  • To keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of world (where relevant).
  • To review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.
  • To 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.

Specific Qualifications:

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.

Previous Work Experience:

Experience working as a QP in the certification of sterile medicinal products in particular Biopharmaceuticals manufactured aseptically.

Specific Knowledge / Skills Competence:

  • 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).

Equal 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.

  • Senior Quality Assurance Specialist

    4 weeks ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Job Title: Senior Quality Assurance SpecialistPCI Pharma Services is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.Main Responsibilities:Review and certify...

  • Senior Quality Assurance Specialist

    4 weeks ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Job Title: Senior Quality Assurance SpecialistPCI Pharma Services is seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.Main Responsibilities:Review and certify...

  • Senior Quality Assurance Specialist

    7 days ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    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...

  • Quality Assurance Specialist

    1 week ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    At 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 month ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control SpecialistAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. 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, work...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control SpecialistAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. 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, work...

  • Senior Quality Assurance Manager

    2 months ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    **Life Changing Therapies. Global Impact.**At PCI Pharma Services, we're committed to making a difference in the lives of patients around the world. Our global network of teams is dedicated to pioneering and shaping the future of pharmaceutical services.**Our Investment is in People**We believe that our people are our greatest asset. That's why we're looking...

  • Senior Quality Assurance Manager

    2 months ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    **Life Changing Therapies. Global Impact.**At PCI Pharma Services, we're committed to making a difference in the lives of patients around the world. Our global network of teams is dedicated to pioneering and shaping the future of pharmaceutical services.**Our Investment is in People**We believe that our people are our greatest asset. That's why we're looking...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full time

    Quality Controller OpportunityWe are seeking a highly skilled Quality Controller to join our team at FMG Repair Services. As a Quality Controller, you will play a critical role in ensuring the highest technical and quality standards are met in the repair and rectification of vehicles.Key Responsibilities:Review and sign off on the full rectification and...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full time

    Quality Controller OpportunityWe are seeking a highly skilled Quality Controller to join our team at FMG Repair Services. As a Quality Controller, you will play a critical role in ensuring the highest technical and quality standards are met in the repair and rectification of vehicles.Key Responsibilities:Review and sign off on the full rectification and...

  • Quality Assurance Specialist

    2 months ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control InspectorAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. As a Quality Control Inspector, you will play a critical role in ensuring the quality of our products and processes.Main Responsibilities:Conduct quality control inspections of incoming materials, work...

  • Quality Assurance Specialist

    2 months ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control InspectorAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. As a Quality Control Inspector, you will play a critical role in ensuring the quality of our products and processes.Main Responsibilities:Conduct quality control inspections of incoming materials, work...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control InspectorAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. As a Quality Control Inspector, you will play a critical role in ensuring the quality of our products and processes.Main Responsibilities:Conduct quality control inspections of incoming materials, work...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control InspectorAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. As a Quality Control Inspector, 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...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control InspectorAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. As a Quality Control Inspector, you will play a critical role in ensuring the quality of our products and processes.Main Responsibilities:Conduct quality control inspections of incoming materials, work...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

    Quality Control InspectorAt PCI Pharma Services, we are committed to delivering high-quality products that meet the needs of our customers and patients. As a Quality Control Inspector, 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...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full time

    Quality Controller OpportunityWe are seeking a highly skilled Quality Controller to join our team at FMG Repair Services. As a Quality Controller, you will play a critical role in ensuring that our vehicles meet the highest technical and quality standards.Key Responsibilities:Review and sign off on the full rectification and repair of vehicles to...

  • Quality Assurance Specialist

    1 month ago

    Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full time

    Quality Controller OpportunityWe are seeking a highly skilled Quality Controller to join our team at FMG Repair Services. As a Quality Controller, you will play a critical role in ensuring that our vehicles meet the highest technical and quality standards.Key Responsibilities:Review and sign off on the full rectification and repair of vehicles to...

  • Quality Assurance Specialist

    2 weeks ago

    Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full time

    Quality 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...

  • Quality Assurance Specialist

    4 weeks ago

    Bridgend, Bridgend county borough, United Kingdom FMG Repair Services Full time

    Quality Controller Job DescriptionWe are seeking a highly skilled Quality Controller to join our team at FMG Repair Services. As a Quality Controller, you will play a critical role in ensuring that our vehicles meet the highest technical and quality standards.Key Responsibilities:Review and sign off on the full rectification and repair of vehicles to...