· Execute qualification activities in accordance with the QC Lab project schedule.
· Ensure the validated status of QC equipment and processes is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.
· Perform qualifications of QC support systems such as temperature controlled environments, water systems and glasswashers
· Drive a risk based validation life cycle utilizing quality risk management principles and tools (e.g. FMEA, HAZOP) to ensure that risks are appropriately identified and documented.
· Provide expertise for the investigation and compliant resolution of non-conformances encountered during qualification / validation activities and site Unplanned Events.
· Generation, peer review and approval of technical documentation
· Perform decommissioning activities on laboratory equipment and temperature controlled environments outside the scope of the QC lab relocation.
Bachelors Degree in Engineering, Science or relevant life sciences
· Minimum of 7+ years in CQV experience in cGMP manufacturing environments
· Extensive knowledge of quality systems and performing validation impact assessments
· Strong understanding of validation principles including but not limited to FEU, laboratory computer systems and analytical equipment
· Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection
· Able to work effectively as a part of a cross-functional team and maintain good relationships with internal and external stakeholders