QA Officer

1. Our investment is in People who make an impact, drive progress and create a better tomorrow.
2. The purpose of role is to perform a Quality Assurance role which supports the certification and release of medicinal products in accordance with regulatory, company and project requirements.
3. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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.