Profile:
Main tasks (primary responsibilities) of the position:
- Validation of Facilities and Equipment associated with Manufacturing, QC Product Development, Laboratory Services
processes
- Generation, Execution and review of Installation, Operational and Performance Qualification (IQ, OQ, PQ)
Support Process Optimisation, Process Risk Assessment and Process Validation activities
- Planning of validation activities in accordance with the Validation Master Plan and schedules and reporting of performed validation
- Liaise with Equipment Vendors to perform Commissioning and Qualification testing.
- Co-ordinate Qualification/Validation activities with inter-departmental representatives
- Responsible for validation elements of equipment and process related SOPs, Change Controls.
To apply for this role you must have the following experience:
- Knowledge in international ISO 13485, GMP guidelines, MHRA, FDA regulations and norms
- Experience in Validation in Medical Device (IVD)/Pharmaceutical Industry
- Proven good documentation practice, technical writing and organization skills
Please e-mail your CV and notice period/ salary requirements to inder.rai@srg.co.uk
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
SRG winners of the 2008 Recruiter Awards for Excellence: Best Candidate Care and Best Health Care/Medical Recruitment Firm.
