Validation Consultant

Cambridge, MA

Posted: 03/26/2019 Employment Type: Contract Industry: Life Sciences Job Number: 228968
Job Description:

·        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.

Requirements: 

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
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