QA Manager
- Location:
- Suffolk jobs
- Salary:
- Salary Competitive
- Company:
- SCI Recruitment for Scientists
- Job type:
- Permanent jobs
- Date posted:
- 29/10/2009 08:55
- Job id:
- 45791310
- Contact:
- Clare Alford
- Ref:
- Totaljobs/15998
QA Manager
Ref: 15998
Located in East Anglia within commuting distance of Cambridge, our client is a large multinational pharmaceutical company. The company can offer excellent opportunities and career progression in pharmaceutical and therapeutics research, clinical supply, development and manufacture. They are currently seeking a QA
Manager for the Clinical Pharmacy Research Services (CPRS).
·You will act as the Qualified Person to certify and release product in accordance with EC Directive 2001/20/EC.
·You will also be Quality representative for CPRS department in the UK.
·You will act as a Qualified Person by certifying and releasing batches of investigational products, in accordance with the requirements of EC Directive 2001/20/EC and other relevant guidance.
·You will maintain the Manufacturing Authorisation for Clinical Trial Manufacturing and any other appropriate licenses.
·You will review label text requests to ensure that regulatory requirements are met.
·Provide an input into the development of all regional Quality documents, and to be an approved QA signatory for Quality documents affecting CPRS UK.
·You will act as the CPRS QA representative to resolve Quality Assurance issues that occur when GMP activities are outsourced to an external vendor.
·Monitor the quality of services and supplies from CPRS vendors.
·Train all regional staff in the requirements of cGMP.
·Provide assistance to the Corporate Quality Compliance Audit team in the auditing key vendors for CPRS and lead internal audits of CPRS facilities.
·Support the local Site Vendor Team in the assessment of external vendors.
The successful candidate will be of graduate calibre with a proven track record in a similar role in QA, including management. It is essential you must also be able to act as a Qualified Person.
Role: Permanent
Location: East Anglia
Salary: Competitive
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