Associate manager - Quality Assurance
Core
Ensuring GMP compliance and quality assurance for Pfizer products manufactured at the Zydus Hospira Oncology site, including batch release, change controls, and complaint management.
Role type
Associate Manager, Quality Assurance (Pharmaceutical Manufacturing)
Builds
Pharmaceutical products (oncology focus) for global distribution
Domain
Pharmaceutical manufacturing / Oncology
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, change control management, complaint investigation and reporting, supplier quality management, QMS compliance, process validation review, training management, statistical analysis, technical writing, audit participation
Preferred skills
Electronic lab systems experience, problem-solving, independent work, mentoring, AI tool usage (ChatGPT/Copilot)
Technologies
Microsoft Office, Microsoft Project, Statistical Software, PDM systems, Pfizer electronic complaint database
Responsibilities
Review and authorize packed batch lots for distribution; manage change controls and regulatory impact assessments; coordinate complaint management and investigation reports; support supplier quality activities for APIs and excipients; review QMS investigations and process validation documentation; manage training for the team; participate in audits and inspections
Seniority
Mid-level Manager, hands-on IC