Senior QA Specialist

3 weeks ago


North East, United Kingdom CK Group Full time

**Salary**:Competitive
- **REF Number**:00054929
- **Consultant**:Phoebe Walker
- **Contact**:01246 457737
- **Date Published**:20.01.2023
- **Sector**:Pharmaceutical
- **Location**:Middlesbrough, North East
- **Discipline**:Quality, Production/Manufacturing

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:

- Reviewand 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,

Tobe 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 cleaningvalidation 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: Ourclient 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 essentialthat applicants hold entitlement to work in the UK. Please quote job reference 54929 in all correspondence.

Phoebe Walker

**Senior Recruitment Consultant**

T: 01246 457730



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