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.
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
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54929 in all correspondence.
You must have the right to work in the UK. Learn more
- Agency: CK Group
- Reference: 54929
Website: CK Group
- Posted: 20th January 2023
- Expires: 17th February 2023