QA Officer
- Location:
- Runcorn jobs
,
Cheshire jobs
- Salary:
- £25 - 30,000
- Company:
- SCANTEC PERSONNEL LIMITED
- Job type:
- Contract jobs
- Date posted:
- 03/11/2009 19:10
- Job id:
- 45838028
- Contact:
- Johnathan Miller
- Ref:
- Totaljobs/SP/ME/S/O /055599
Interim QA Officer required for our pharmaceutical client based in Runcorn. The initial appointment is for 6 to 12 months however this may be extended depending on performance and for the right candidate has the possibility of going permanent.
Purpose of Role:
We have temporary vacancy in our QA department for a Quality Assurance Officer. The purpose of this role is to develop, implement and maintain quality standards and systems to ensure that products comply with Marketing Authorisations, specifications and cGMP
Key Results Area:
- LIMS implementation (reviewing/approval of validation documentation)
- Qualification of packaging equipment validation.
- Qualification of cleanroom builds and aseptic manufacturing equipment
- To support manufacturing and other operations in the development, implementation and maintenance of cGMP standards
- To identify, design and deliver cGMP training to support improved application of cGMP standards
- To review and approve quality documentation to ensure compliance with cGMP
- To prepare and complete product quality reviews to ensure compliance with regulatory requirements.
- To close out failure investigations and preventative actions to reduce repeat failures
- To review and approve batch manufacturing documentation within agreed timelines to support product release
- To carry out audits to support the identification, actioning and close out of non-compliance issues.
Qualifications/Experience:
- Must have experience with key results 1,2 and 3
- Ideally degree qualifications in scientific discipline.
- Experience in pharmaceutical industry in similar role
- Experience in Blow Fill Seal (BFS) technology
- Knowledge and understanding of cGMP, (Annex 1, Annex 15), 21 CFR Part 11, GAMP.
- Good validation experience from a QA perspective.
