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We are currently looking for a QA Compliance Specialist to join a leading Pharmaceutical company based in the Cambridgeshire area.
As the QA Compliance Specialist you will be responsible for up to date specifications, systems and procedures within the company's Quality System to ensure compliance with Marketing Authorisations and regulatory requirements.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the QA Compliance Specialist will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for generation of the Annual Product Quality Reviews (PCRs) of products manufactured and/or certified on site as per Company's processes in line with GMP and Regulatory standards.
2. You will be supporting the Regulatory Affairs group on queries and topics concerning Quality and Licensing under the guidance of the Senior Management team and QPs.
3. You will have an opportunity to supports the company's self-inspection programme and performs internal audits in support of this when required.
4. You will be supporting in GMP failure investigations, working closely with the Production Management team by communicating and monitoring implementation of CAPAs.
To be successful in your application to this exciting opportunity as the QA Compliance Specialist we are looking to identify the following on your profile and past history:
1. Relevant degree in a Scientific Discipline
2. Proven industry experience in the Pharmaceutical or Life Sciences industry in a Quality Assurance role
3. A working knowledge and practical experience with Product Quality Reviews (PCRs), CAPAs, Quality Compliance, Regulatory compliance, QMS Management.
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.