Associate Manager - MSAT (C&Q)
Core
Evaluate, review, and approve validation master plans, protocols, and reports for sterile dosage form facilities to ensure compliance with regulatory requirements and company standards.
Role type
Associate Manager, Quality Assurance and Control (Validation)
Builds
Validation documentation, qualification reports, and compliant manufacturing processes for sterile injectable formulations.
Domain
Pharmaceutical manufacturing (sterile dosage forms) and Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Good Manufacturing Practices (GMP), validation principles, statistical analysis, regulatory compliance (cGMPs, FDA), change control management, deviation investigation, root cause analysis (DMAIC), document review, data analysis
Preferred skills
sterile product experience, medical device experience, regulatory audit experience, AI tool usage (generative AI), mentoring
Technologies
Global Document Management System, System Application & Products, Quality Tracking System, Autoclave, Vial washing, Depyrogenation tunnel, Vial filling, stoppering and sealing, Solution preparation, Filter integrity testing devices, Visual inspection equipment, Packing equipment, Cleaning Validations, IQ/OQ/PQ protocols, GAMP, ISO guidelines, 21 CFR part 11
Responsibilities
Evaluate and approve validation master plans, protocols, and reports; troubleshoot validation issues for equipment and processes; conduct statistical analysis of testing results; guide writing and review of validation documents; manage routine Quality systems (Change Control, Investigations); support product transfers and new product development; compile validation documents and results; develop facility qualification reports; review DQ, FAT/SAT activities and IQ/OQ/PQ protocols; perform alarm assessment during qualification; investigate qualification deviations; prepare traceability matrices.
Seniority
Mid-level Manager (6-8 years experience)
