Process Quality Excellence Specialist

2 weeks ago

Slough, United Kingdom CK GROUP Full time

CK Group are recruiting for a Process Quality Excellence Specialist to join a Biopharmaceutical company in a hybrid working role on an initial 12-month contract basis. The role has been determined as inside IR35 and contracting options are Umbrella companywith guide rates (£45.67 per hour) or PAYE via CK (£33.49 per hour).
**Process Quality Specialist Role**:
The main purpose of the role will be to:

- To support the Process Quality Excellence Lead for GCSO in developing and maintaining its clinical quality systems/procedures and ensuring quality and compliance risks are appropriately identified and mitigated.
- To ensure compliance with ICH GCP and relevant local and international regulations and to ensure inspection readiness.
- Participate in Audit and Inspection planning.
- Represent or ensure GCSO representation and preparation during audits/inspections.

**Your Background**:

- Strong pharmaceutical experience, preferably in a global Quality Assurance or a Clinical Development setting.
- In depth experience of GCP, including hands on experience in global GCP audits and/or inspections.
- FDA/EMA inspection readiness experience is essential.

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53623 in all correspondence.

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