Description
Duties- You will be required to provide validation support to all areas within the Quality Control departments to ensure equipment is validated as required.
- You will be required to write and execute validation protocols following organisational standards and to promptly write reports on completion of execution of the validation/verification studies.
- You will be required to review data generated from validation activities undertaken and bring to the attention of the team manager and investigate any trend deviation or failure identified.
- You will be required to monitor ongoing validation exercises and provide regular updates on progress, communicating possible issues that may affect timelines and milestones.
- You will be required to actively make recommendations following validation or technical studies.
Qualifications and Experience:
- Strong cGMP background in the Biological or Pharmaceutical industry.
- Strong back ground in equipment validation including thermal equipment and laboratory instrumentation.
- Strong background in working with 21 CFR part 11.
- Experience of QC testing.
- Experience in sterile manufacturing and testing
- Essential: Minimum of 3 to 4 years experience in equipment validation.
- Experience of writing validation documents - URS's, IQ, OQ and PQ.
This is an excellent opportunity to join a global organisation, with a strong product pipeline. If you are interested in this opportunity, please contact Reshma Patel on immediately with an updated CV.