Quality Assurance

4 days ago

Oxford, United Kingdom taylorollinson Ltd Full time

**Quality Assurance - Audits and Inspections**

**Location: Oxfordshire**

**Sector: Pharmaceutical**

Our client is a leading Pharmaceutical CRO based in Oxfordshire and is now seeking an experienced QA professional to join the company and support with the provision of Quality Assurance within Audits and Inspections. Due to the needs of the company thisis a site-based position.

**The role**:
Responsibilities will include:

- Takes ownership of Supplier Quality, including the qualification of suppliers. Supports the process for any other suppliers requiring qualification for other company sites, as and when needed.
- Ensure completion of assigned deliverables on time and in full.
- Liaise with members of other departments to ensure timely and successful completion of tasks.
- Liaise with customers on matters of Quality (internal and external, all levels).
- Performs activities related to regulatory inspections and customer audits of the Oxford site, including backroom support, assisting with audit responses.
- Own/approve key performance indicators such as deviations, change controls and CAPAs.
- May deputise for the Audits and Inspections Manager.
- Provide advice to other departments to ensure their compliance to company policies, best practice and cGMP.
- Actively promotes Quality Culture across the site.
- Promotes and contributes to continuous improvement.

**Experience expectations**:
Suitable applicants will have;
- Previous experience with external supplier audits and internal auditing procedure.
- Experience working within a GMP environment
- Experience with 21CFR, ISO 9001, MHRA Orange Guide
- Approval of non-compliance investigations (e.g., deviations, OOSs, etc ).
- Approval of CAPAs and Change Controls. Work with all required departments to ensure that CAPAs that are raised as a result of any audit/inspection non-conformity are SMART and that CAPAs are closed by the due dates (for activities within QA control. Foractivities that involve other departments, support where possible to help ensure the timelines are met).

**The Package**:
Our client offers an opportunity to work for a leading Pharmaceutical company on a permanent basis with a competitive annual salary and benefits package.

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