Tandem Project Management Ltd. provides expert project management services across diverse sectors.
Develop and review CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, and PQ protocols, in line with cGMP and internal quality standards.
Ensure validation data is accurately recorded and maintained in accordance with GDP and site documentation standards.
Participate in system handover processes and ensure validated systems are ready for operational use.
Lead and execute CQV activities for lyophilisation systems, including process equipment, utilities, and supporting systems.
Participate in risk assessments and support the development of validation strategies for lyophiliser and associated systems.
Ensure adherence to project schedules by coordinating and executing commissioning and validation tasks within agreed timelines.
Support deviation investigations, change controls, and CAPAs associated with CQV activities.
Support continuous improvement initiatives within the CQV function to enhance efficiency and compliance.
Work cross-functionally with Engineering, Quality, and Manufacturing teams to ensure alignment on CQV scope and objectives.
Review vendor documentation and ensure compliance with design specifications and regulatory expectations.
Minimum of 5 years’ experience in a CQV or Validation role within a GMP-regulated pharmaceutical or biopharmaceutical environment.
Bachelor’s degree in Engineering, Science, or a related discipline.
Strong experience with lyophilisation systems and related utilities.
Experience preparing and executing validation documentation for complex systems.
Excellent understanding of CQV principles, validation lifecycle management, and regulatory requirements (FDA, EMA, ISPE, GAMP 5).