Senior Specialist, QA (Validation)
Core
Provide Quality oversight for engineering and validation activities to ensure medicines are manufactured to the highest quality and safety standards.
Role type
Senior QA Specialist (Validation)
Builds
Validated pharmaceutical manufacturing processes and products
Domain
Biopharmaceutical manufacturing / Life Sciences
Deliverable
client delivery
Required skills
Validation Master Plan review, process validation protocols, cGMP compliance, regulatory standards, root cause analysis, CAPA management, Continued Process Verification
Preferred skills
Independent operation, safety focus, quality focus, timeline management
Technologies
GMP facilities, Validation Master Plan, Process Performance Qualification, Corrective and Preventive Actions (CAPAs), Continued Process Verification (CPV)
Responsibilities
Review and approve Validation Master Plan and process validation protocols; Provide QA oversight during validation execution; Review and approve discrepancies, deviations, and CAPAs; Review and approve validation reports; Review and approve Continued Process Verification protocols and reports
Seniority
Senior, hands-on IC
