Lead GMP Quality Control Specialist

2 weeks ago


Bristol, Bristol, United Kingdom eXmoor Pharma Concepts Limited Full time
Job Title: Lead GMP Quality Control Specialist

Job Summary:

eXmoor Pharma Concepts Limited is seeking an experienced Lead GMP Quality Control Specialist to join our team. As a key member of our Quality Control department, you will be responsible for ensuring that our analytical services laboratories operate to a GMP standard, meeting all local and regulatory requirements.

Main Responsibilities:

  • Supervise and manage GMP QC staff, including Senior QC Scientists and QC Scientists, to ensure they perform their roles effectively.
  • Develop and implement systems for reporting QC testing data to QA, ensuring timely completion of quality records and metrics reporting.
  • Lead OOS/OOT investigations and support QC staff in completing these records, working closely with Production and QA teams to drive closure.
  • Take the lead in completing quality risk assessments related to QC and develop systems for communicating in-process testing data with the Production team.
  • Set up and manage systems for trending critical quality attributes and schedule/manage all QC sample testing for raw materials, in-process, and final product/stability test samples.

Requirements:

  • Minimum BSc level education in a relevant subject area or equivalent years of experience.
  • Considerable experience (4+ years) working within GMP QC Operations.
  • Good understanding of Good Manufacturing Practice as applied to small-scale biopharmaceuticals and Cell & Gene Therapies for clinical trials.
  • Technical expertise in analytics related to ATMPs, including HPLC, FACS, PCR, qPCR, etc.
  • Experience managing a team of QC Scientists, including leading, developing, motivating, and organizing.
  • Aptitude for coaching and mentoring a team.
About eXmoor Pharma Concepts Limited:

eXmoor Pharma Concepts Limited is a globally recognized team of scientists, consultants, and engineers providing translation consultancy, process development services, capital project design, licensing, and GMP manufacturing for early-phase clinical trials.

Why Join Our Team:

  • Opportunity to work on a wide range of client projects in a rapidly growing business.
  • Develop your quality management career in a dynamic and supportive environment.
  • Collaborate with a globally recognized team of experts in the biopharmaceutical and Cell & Gene Therapy industries.


  • Bristol, Bristol, United Kingdom Broadstone Full time

    Job SummaryWe are seeking a highly skilled GMP Reconciliation Specialist to join our team at Broadstone. The successful candidate will be responsible for assisting in the rectification and equalisation of GMPs, preparing and analysing data, calculations and letters/reports for review by colleagues, and system updates.Key ResponsibilitiesWorking closely with...


  • Bristol, Bristol, United Kingdom Broadstone Full time

    Job PurposeThe role of the GMP Reconciliation Specialist is to assist in the rectification and equalisation of GMPs. This involves preparing and analysing data, calculations and letters/reports for review by colleagues, and system updates.Key ResponsibilitiesWorking closely with the administration teams, you will be actively involved in all aspects of GMP...


  • Bristol, Bristol, United Kingdom Broadstone Full time

    Job Title: Projects AdministratorJob Summary:We are seeking a highly skilled Projects Administrator to join our team at Broadstone. As a key member of our administration team, you will play a crucial role in the rectification and equalisation of GMPs. Your primary responsibility will be to prepare and analyse data, calculations, and letters/reports for...


  • Bristol, Bristol, United Kingdom HCS Control Systems Ltd Full time

    Job Title: Document Control and Records Configuration ManagerJoin HCS Control Systems Ltd as a Document Control and Records Configuration Manager and play a critical role in the success of our projects. As a key member of our team, you will be responsible for establishing, managing, and leading document control processes from the ground up, ensuring that all...


  • Bristol, Bristol, United Kingdom HCS Control Systems Ltd Full time

    Job Title: Document Control and Records Configuration ManagerJoin HCS Control Systems Ltd as a Document Control and Records Configuration Manager and play a critical role in the success of our projects. As a key member of our team, you will be responsible for establishing, managing, and leading document control processes from the ground up, ensuring that all...


  • Bristol, Bristol, United Kingdom HCS Control Systems Ltd Full time

    Job Title: Document Control and Records Configuration ManagerJoin HCS Control Systems Ltd as a Document Control and Records Configuration Manager and take on a challenging role that requires strong organizational skills, attention to detail, and a commitment to accuracy and quality in document management.This is an exciting opportunity to establish, manage,...


  • Bristol, Bristol, United Kingdom HCS Control Systems Ltd Full time

    Job Title: Document Control and Records Configuration ManagerJoin HCS Control Systems Ltd as a Document Control and Records Configuration Manager and take on a challenging role that requires strong organizational skills, attention to detail, and a commitment to accuracy and quality in document management.This is an exciting opportunity to establish, manage,...


  • Bristol, Bristol, United Kingdom North Bristol NHS Trust Full time

    Job SummaryThis is an exciting opportunity for a pharmacy professional to join the South West Regional Quality Assurance team at North Bristol NHS Trust. As a Pharmacy Quality Assurance Specialist, you will work collaboratively to enhance quality assurance and quality management across the region, supporting NHS England Specialist Pharmacy Service quality...

  • Pharmacy Specialist

    4 days ago


    Bristol, Bristol, United Kingdom North Bristol NHS Trust Full time

    About the RoleWe are seeking a motivated and experienced Pharmacy Professional to join our South West Regional Quality Assurance team at North Bristol NHS Trust.As a Pharmacy Specialist - Quality Assurance, you will work collaboratively with our team to enhance quality assurance and quality management across the SW region. Your expertise in pharmaceutical...


  • Bristol, Bristol, United Kingdom HCS Control Systems Ltd Full time

    Job DescriptionThe Sizewell C MEH Alliance is seeking a highly skilled Document Control and Records Configuration Manager to join their team. This is an exciting opportunity to establish, manage, and lead the document control processes from the ground up, ensuring that all project documentation is accurately recorded, maintained, and accessible throughout...


  • Bristol, Bristol, United Kingdom Altrad UK, Ireland & Nordics Full time

    Job Title: Document Control SpecialistJoin Altrad UK, Ireland & Nordics as a Document Control Specialist and take on a challenging role that requires strong organizational skills, attention to detail, and a commitment to accuracy and quality in document management.About the Role:We are seeking an experienced Document Control Specialist to lead the...


  • Bristol, Bristol, United Kingdom Altrad UK, Ireland & Nordics Full time

    Job Title: Document Control SpecialistJoin Altrad UK, Ireland & Nordics as a Document Control Specialist and take on a challenging role that requires strong organizational skills, attention to detail, and a commitment to accuracy and quality in document management.About the Role:We are seeking an experienced Document Control Specialist to lead the...


  • Bristol, Bristol, United Kingdom North Bristol NHS Trust Full time

    About the RoleWe are seeking a highly skilled and experienced Pharmaceutical Quality Assurance Specialist to join our team in the South West region. As a key member of our Quality Assurance team, you will play a vital role in ensuring the highest standards of quality and safety in pharmacy services across the region.Key ResponsibilitiesProvide expert quality...


  • Bristol, Bristol, United Kingdom arm limited Full time

    Quality Assurance Role Overview We are seeking a highly skilled Quality Assurance Specialist to join our global team at arm limited. This role will involve supporting the development of our QMS internal audit programme to verify that organisational internal controls and operational procedures comply with international standards. Key Responsibilities: ...


  • Bristol, Bristol, United Kingdom HCS Control Systems Ltd Full time

    About the RoleThe MEH Alliance is seeking a highly skilled Document Control and Records Configuration Manager to join their team. This is an exciting opportunity to establish and manage document control processes from the ground up, ensuring accurate recording, maintenance, and accessibility of project documentation throughout the lifecycle.As a key member...


  • Bristol, Bristol, United Kingdom Computerworld Personnel Ltd Full time

    Process Quality Specialist - Tewkesbury, GloucestershireOur client, a leading manufacturer, is seeking a Process Quality Specialist to join their Engineering team.Key Responsibilities:Manufacturing Non-conformances within processing, facilitating and progressing.Supporting manufacturing process improvements.Developing and creating inspection...


  • Bristol, Bristol, United Kingdom https:www.energyjobline.comsitemap Full time

    We are seeking a skilled Lead Quality Assurance Specialist to join our team at https://www.energyjobline.com/sitemap. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality in our Contingent Workforce Solution (CWS).Purpose of the Lead Quality Assurance Specialist:The successful candidate will be...


  • Bristol, Bristol, United Kingdom Framatome Full time

    Framatome is a leading international player in the nuclear energy market, renowned for its innovative solutions and value-added technologies. As a major player in the industry, the company designs, manufactures, and installs components, fuel, and instrumentation and control systems for nuclear power plants.The company's expertise helps its customers improve...


  • Bristol, Bristol, United Kingdom Rise Technical Recruitment Full time

    We are seeking a Quality Assurance Specialist to join our team at Rise Technical Recruitment. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services. You will work closely with our production team to identify and resolve any quality issues that may arise.As a Quality Assurance Specialist, you will...


  • Bristol, Bristol, United Kingdom CBSbutler Holdings Limited trading as CBSbutler Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a Quality Assurance Specialist to join our team at CBSbutler Holdings Limited trading as CBSbutler. The successful candidate will be responsible for conducting tasks in line with Conformance Engineering principles, leading to a reduction in the Cost of Non-Quality by generation of business...