QA Manager

We are currently looking for a QA Manager to join a leading Biotech company based in the Glasgow area.



KEY DUTIES AND RESPONSIBILITIES:

Your duties as the QA Manager will be varied however the key duties and responsibilities are as follows:

1.

Manage the QA Operations group to ensure manufacture, testing and release of products is carried in a compliant manner and in adherence to the required manufacturing, testing and release schedules

2.

Provide QA oversight and input to all site activities including; review and approval of deviations, change requests, specifications, Standard Operating Procedures, Manufacturing and Analytical Procedures.

3.

Manage a team of up to 17 Quality professionals

4.Assure compliance of procedures according to internal guidelines and UK/EU/US/ICH and other region specific guidance.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the QA Manager we are looking to identify the following on your profile and past history:

1.

Relevant degree in a science related subject

2.

Proven industry experience in Quality assurance within the pharmaceutical industry and a minimum of 5 years QA experience within an EU authorised GMP manufacturing site.

3.

A working knowledge and practical experience in QA Management of biotech and/or low bioburden/sterile dosage forms.

Key Words:
QA, Quality Assurance, Sterile, Manufacturing, Biologics, GMP, FDA< MHRA, Auditing, Chance control, documentation, deviation, capa




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