Manager Compliance
Core
Ensuring sustainable GMP compliance and quality assurance for Pfizer products manufactured at the Zydus Hospira Oncology site.
Role type
Manager, Quality Assurance Compliance
Builds
Pharmaceutical products for global distribution
Domain
Biopharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review and release authorization, regulatory impact assessment, change control management, complaint management, QMS compliance, process validation review, supplier management, new product launch support, tech transfer support
Preferred skills
Master's degree, aseptic process experience, training design and methodology, AI tool proficiency (ChatGPT, Microsoft Copilot)
Technologies
PDM systems, Pfizer electronic complaint database
Responsibilities
Oversee quality assurance compliance and GMP adherence at the manufacturing site; Review and authorize packed batch lots for distribution; Manage regulatory impact assessments and change controls; Coordinate complaint investigations and approvals; Approve QMS investigations and process validations; Support new product launches and technology transfers; Manage local process performance for Pfizer global SOPs
Seniority
Manager, hands-on IC
