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QA Officer in Bridgend

2 months ago

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

Job ID: JR111509

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.

General Purpose of Role:

To perform a Quality Assurance role which supports the certification and release of medicinal products in accordance with regulatory, company and project requirements.

Main Responsibilities:

  • Support QPs in execution of their legal and operational duties.
  • Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
  • Reporting of metrics for systems within scope of responsibility.
  • Support and host client audits of the PCI Bridgend facility.
  • Support delivery of site/departmental projects and objectives.
  • Support continuous improvement, validation and technical services activities.
  • Author standard operating procedures.
  • Provide QA and GMP related training.

Specific Qualifications:

HNC, HND or degree (or equivalent) in a life sciences subject or suitable experience in a Quality Assurance or technical role within the pharmaceutical industry.

Previous Work Experience:

  • Ideally, candidates will have experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
  • Candidate's with experience in a Quality Assurance role with a demonstrable, transferable skills may be considered.

Specific Knowledge / Skills Competence:

  • Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
  • Strong communication skills.
  • The ability to introduce, co-ordinate, complete and report on projects.