Commissioning and Qualification - QC Lab

Ihre Aufgaben:

• C&Q SME for QC Laboratory scope.
• Plan, coordinate, and execute commissioning, and qualification activities for QC laboratory systems, equipment, and support utilities as needed (e.g., analytical instruments, laboratory systems, HVAC, and water systems).
• Coordination of execution activities with supporting CSV Team and global IT teams.
• Lead C&Q testing activities supported by external vendors and/or contractors
• Develop any supporting validation plans related to scope of execution.
• Develop and review Qualification Protocols (IQ/OQ/PQ), commissioning documents, and final reports, ensuring compliance with relevant standards (GxP, FDA, EMA, ISO, etc.).
• Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
• Maintain and reporting of C&Q status to the C&Q Lead, which can be reported into project stakeholders meetings (e.g. Tier 1 meetings, Wall meetings).
• Generate, review, approve, CQV test scripts in accordance with Verification Plans and any applicable site commissioning or validation plans or procedures.

Ihr Profil:

• Bachelor’s degree in Life Sciences or Engineering
• 5+ years of commissioning, qualification, or validation experience in a GMP environment in a Life Sciences relevant discipline
• Familiarity with laboratory instruments such as HPLC, GC, UV-Vis spectrophotometers, and other analytical equipment.
• Experience with computer systems validation (CSV) for laboratory systems.
• Previous experience in authoring CQV lifecycle documents necessary
• Strong knowledge of qualification and validation processes for laboratory systems and equipment