Hobson Prior is seeking a QA Audit Compliance Manager to ensure GMP/GDP compliance at third-party service providers and within internal facilities. The successful candidate will play a key role in establishing external QA Audit and internal self-inspection plans, conducting audits, and coordinating with internal personnel and suppliers. This role also involves managing, reviewing, and approving change controls, deviations, and CAPAs related to internal pharmaceutical operations facilities.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities

• For this role, Ensure GMP/GDP compliance at third-party service providers and within internal facilities.
• Lead in establishing external QA Audit and internal self-inspection annual plans.
• Conduct GMP/GDP audits and self-inspections and coordinate with internal personnel and suppliers to schedule, execute, and follow up with audit observations.
• Promptly report critical self-inspection findings to the Responsible Person and Management.
• Create, implement, maintain, and work with Vendors on establishing Quality Agreements where needed.
• Interface between quality/regulatory/compliance personnel and operations to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements.
• Manage, review, and approve change controls, deviations, and CAPAs related to the internal pharmaceutical operations facilities.
• Write, review, and/or approve internal SOPs governing compliance-related operations and other GMP/GDP and regulatory-related documentation.

Requirements

• University degree in Pharmacy, Chemistry, or a related technical/science field (master level minimum).
• Experience in Auditing, with demonstrated experience as a Lead Auditor.
• Knowledge and understanding of drug product development, manufacturing processes, quality control, packaging, and distribution aspects.
• Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP, and ability to interpret and implement quality standards.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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