Senior QA Specialist

2 weeks ago


Middlesbrough, United Kingdom CK GROUP Full time

CK Group are recruiting for a Senior QA Specialist, with a focus on Validation, on behalf of a global Pharmaceutical CDMO to be based at their site in Middlesbrough on a permanent basis.
**About the role**:
The Senior QA Specialist will serve as the QA liaison with the Facility, Engineering and Validation organisations to support company goals, client projects and continuous improvement initiatives.
**Your responsibilities will include**:

- Review and approve equipment qualification protocols such as IQ/OQ/PQ.
- Support the Computerized System Validation Lifecycle to ensure compliance to 21 CFR Part 11, Eudralex Annex 11, and applicable FDA/EMA Guidance's on electronic data integrity.
- Review and approve Protocols and Summary Reports for Process Validation such as PPQ’s, Engineering studies, Cleaning Validation, etc.
- Support the Risk Management Program to evaluate and mitigate risks associated with equipment and facilities,

**To be considered for the position you should have the following skills and experience**:

- Bachelor’s Degree in a Science or Engineering field with 4 years of experience
- Master’s Degree preferred.
- Experience in CSV, process validation and cleaning validation preferred.
- Good understanding of Upstream and Downstream Manufacturing process.
- Experience in writing deviation and investigations.
- Able to work in a team setting and independently under minimum supervision.

**The benefits**:
Our client offers a range of employee benefits, including:

- Competitive Salary
- Company Pension Scheme
- Flexible working hours
- Enhanced holiday entitlement
- Holiday purchase scheme
- Future development opportunities

**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54929 in all correspondence.


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