Associate Manager
AssociateManagerQualityAssurance
“Associate Manager - Quality Assurance at Associate Manager. Skills: Quality Assurance, Technology transfers, Validations. Review, approval of change controls. Ensure compliance of SOPs”
What You'll Achieve.
ensure the compliance of SOPs; ensure validation life cycle; meet regulatory expectations; meet global regulatory and Pfizer quality standards
Industry & Context.
Proactive approach to problem-solving
What They're Looking For.
Must Have
B. Pharm/ M. Pharm /M. Sc, 6-7 years of experience in sterile injectable Quality Assurance /Technology transfers / validations, Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards, critical thinking skills, Ability to work effectively within own team and interdepartmental teams, Good working knowledge of Microsoft Excel and Word, Proactive approach to problem-solving
What You'll Do.
approval of change controls
Ensure compliance of SOPs
Review and approval of validation protocols
Support production related documents review
Ensuring Zero Defect Technology transfer
Quality Support and review of Scale-up
Reviews of Process validation protocols
Review of Optimization Report
Responsible to manage New Product Introduction
Review and approval of Project validation protocols
Review of Analytical Method Transfer
Continuous improvement of templates
Evaluate and review commercial drug batches
Approve change control activities
Independently assess Change Control activities
Investigate and document Quality Assurance deviations
Ensure regulatory compliance with GxP
Provide Quality Review and oversight
How You'll Work.
Team & Collaboration
Ability to work effectively within own team and interdepartmental teams
Process & Methodology
New Product Introduction (NPI) projects
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