QA Manager - Clinical Pharmacy Services - Suffolk - up to £49k
- Location:
- Haverhill jobs
,
Suffolk jobs
- Salary:
- £36000 - £49000 per annum + excellent benefits
- Company:
- Cranleigh Recruitment Solutions
- Job type:
- Permanent jobs
- Date posted:
- 29/10/2009 17:14
- Job id:
- 45797882
- Contact:
- Sally Emmett
- Ref:
- Totaljobs/1973
Manager QA, Clinical Pharmacy Services - Pharmaceuticals - Suffolk / Cambridgeshire £36 - £49k
A leading pharmaceutical company based in the Suffolk / Cambridgeshire borders is looking to recruit an experienced Quality Assurance professional to manager their Clinical Pharmacy Research Services (CPRS) and support EU, US and International company sponsored clinical trials.
As QA Manager you will be required to act as the Qualified Person (QP) to certify and release products in accordance with EC Directive 2001/20/EC and to be the Quality representative for CPRS department in the UK.
Additional Duties will include:
- Maintaining the manufacturing authorisation for Clinical Trial Manufacturing and any other appropriate licences
- Reviewing label text requests to ensure that regulatory requirements are met
- Providing input into the development of all regional Quality documents, and to be an approved QA signatory for Quality documents affecting CPRS UK
- Acting as the CPRS QA representative to resolve Quality Assurance issues
- Monitoring the quality of services and supplies from CPRS vendors
- Training all regional staff in the requirements of cGMP
- Providing assistance to the Corporate Quality Compliance Audit team in the auditing of key vendors for CPRS and lead internal audits of CPRS facilities
- Support the local Site Vendor Team in the assessment of external vendors
To be considered for this opportunity the following requirements are essential:
- Minimum BSc degree in Pharmacy, Chemistry or Microbiology with substantial industry experience working in Quality Assurance, including management
- Experience in working with investigational medicinal products would be ideal
- Eligible to act as a Qualified Person (QP)
- Proven ability to succeed in a key management / leadership position and build effective relationships with personnel.
Salary £36 - £49k in line with experience + excellent benefits package that includes final salary pension scheme, share options, medical cover etc.
