Our client, a major Pharmaceutical company is looking for a Validation Expert to join their team in Liverpool
The main experience required is Laboratory Equipment Validation, with particular experience in Isolators. The ideal candidate needs to show at least 5 years’ experience in Sterility Testing and Full Finish type isolators. Experience in DHP Sanitation is essential and knowledge and experience of QC, Facilities and HVAC would be an advantage.7-8 months initially with a view to an extension.
The role is to:
- co-ordinate the validation activities within the production facilities, ensuring that the appropriate site and regulatory standards are applied, operating within the required standards of HSE, company Quality Systems and policies in accordance with Orange Guide, EU and CFR regulations.
- perform accurate and reliable laboratory tests and generate, report and approve results to cGMP standard, in accordance with current company requirements and SOPs.
- write and execute validation protocols following ICH guidelines and other organisational standards; to promptly write reports on completion of execution of the validation/verification studies.
- participate in planning and execution of projects including monitoring ongoing validation exercises and providing regular updates on progress, communicating possible issues that may affect timelines and milestones.
- ensure that the maintenance, qualification and calibration of laboratory equipment used is up to date and at the required GMP standards and to participate in method/instrument troubleshooting.
Qualifications and experience:
- strong cGMP background in the Biological or Pharmaceutical industry
- sterile manufacturing
- validation of QC Laboratory equipment.
- knowledge in the validation QC facilities and utilities.
- QC equipment validation.
- generating and executing IQ, OQ, PQ on GMP equipment.
- exposure to CSV and IT systems is desirable.
- Experience of QC testing techniques and industry practices is desirable., to include Biological and Chemistry testing
- eequipment validation
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