Commercial Affiliate QA Manager (GMP/GDP)

Jocelyn Blackham is recruiting for a Commercial Affiliate QA Manager (GMP/GDP) to join an exciting biopharmaceutical company, with a global presence at their site based just outside of Basel. This position is offered on a contract basis for 12 months.

Commercial Affiliate QA Manager (GMP/GDP) role:

• Develop, maintain and drive compliance of the Affiliate Quality Management Systems against the company’s Quality Policies, industry standards and local GMP/GDP related regulatory requirements.
• Manage Affiliate documentation and training records within Quality System, in collaboration with HQ QA and affiliate. Review and approve local (GxP related) standard documentation and develop local Quality related procedures as appropriate, in accordance with HQ QA principles and processes.
• Ensure appropriate and timely management of non-conformances related to relevant GxP (GMP/GDP): deviations, change controls, internal and external CAPAs, Quality Events.

Key duties will include:

• Monitor quality system performance versus local quality relevant GxP and Idorsia requirements via use of pertinent quality and compliance metrics and goals.
• Eventually perform batch record reviews and deviation review and approval as a Qualified Person (QP) or on behalf of the QP, and perform batch release, if qualified and accepted as such by the local competent authority.

In order to be considered for this role, you will be required to have the following qualifications, skills and experience:

• Graduate Degree in Pharmacy, or other scientific or health related fields (BSc at minimum); additional knowledge in Quality Assurance/Compliance and Auditing.
• Fluent in English both written and spoken required; intermediate knowledge of French is a plus.
• Experience: at least 5 years of experience in pharmaceutical industry in QA and PV field including GDP for commercial products and GMP.
• Experience in regulatory inspection management, interactions with health authorities.
• Experience as a QP is a plus.

Apply:

Please quote job reference 103253 in all correspondence.