Quality Assurance Manager (GCP)

Austin Fraser
11 Mar 2018
15 Mar 2018
Contract Type
Full Time
My client is a hugely exciting Pharmaceutical business with a new product in the market and development projects on the go. Due to expansion they are looking to appoint a GCP QA Manager who will join the Quality Assurance & Clinical team to deliver global GCP compliance across the business. This position provides an exciting opportunity to play a key role in the team to establish a high level of compliance across the current and future product portfolio. If you have a strong background in Quality & Clinical Operations and work in a collaborative and hands-on style, then this opportunity is for you.


The GCP QA Manager will support the development and maintenance of the GxP aspects of the Quality Management System. This will encompass all GxP disciplines but in particular, to assure compliance with internal and external GCP standards, including GCP audits, to provide necessary GCP training, and to lead the preparation, conduct and follow-up for GCP Regulatory Authority Inspections.

Qualifications and Experience:

* Comprehensive knowledge of ICH GCP, and good knowledge of EU and US FDA regulatory standards
* Experience with Regulatory Authority GCP inspection processes
* Science degree in relevant scientific discipline
* At least 5 years' experience in GCP QA or a similar compliance role including knowledge of CAPAs, change control and SOP deviations
* Trained GCP auditor or having sufficient knowledge and experience to assess, select and manage/oversee contract GCP auditors and maintain the audit schedule
* Previous experience preparing and revising GCP SOPs
* Some prior training experience preferable

You will be rewarded with a great salary and benefits, and the personal satisfaction of working on life changing products at the fore front of this niche pharmaceutical area.

If this sounds of interest, please apply ASAP as my client is currently shortlisting for interview.

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