Pfizer
AssociateManager-QualityAssurance
Neural analysis suggests this role is
optimal for Mid candidates.
“Associate Manager - Quality Assurance at Pfizer. Skills: Quality Assurance, Technology transfer, Validations. Evaluate commercial drug batches. Ensure Zero Defect Technology transfer”
What You'll Achieve.
ensure compliance with established specifications; meet regulatory expectations; meet global regulatory and Pfizer quality standards
Industry & Context.
critical thinking skills; Proactive approach to problem-solving
What They're Looking For.
Must Have
B. Pharm /M. Pharm/M. Sc, 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance /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.
Evaluate commercial drug batches
Ensure Zero Defect Technology transfer
Quality Support for Scale-up batches
Review Process validation protocols
Review Optimization Report
Manage New Product Introduction projects
Review validation protocols
Review Analytical Method Transfer
Improve templates for presentations
Review SOPs related to technology transfer
Review validation protocols
Support production documents review
Approve investigations
Assess Change Control activities
Investigate Quality Assurance deviations
Ensure regulatory compliance GxP
How You'll Work.
Team & Collaboration
Ability to work effectively within own team; Ability to work effectively within interdepartmental teams
Process & Methodology
New Product Introduction (NPI) projects
Full Job Description
**What You Will Achieve** In this role, you will: * Evaluate and review commercial drug batches to ensure compliance with established specifications. * Ensuring Zero Defect Technology transfer for new product transfers into site. * Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations. * Reviews of Process validation protocols and reports to meet regulatory expectations. * Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data. * Responsible to manage New Product Introduction (NPI) projects. * Review and approval of Project validation protocols, QRM’s, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports. * Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned in the other transfer sites. * Continuous improvement of templates for presentations, timelines, trackers, and other tools, * Review , approval and ensure the compliance of SOPs related to technology transfer . * Review and approval of validation protocols , PRQs and PR’s to ensure validation life cycle . * Support production related documents review and approvals * Approve investigations and change control activities to maintain compliance with configuration management policies. * Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. * Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. * Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. **Here Is What You Need**(Minimum Requirements) * **Qualification :** B.Pharm /M. Pharm/M.Sc * **Experience :** 6 to 7 years of experience in sterile injectable technology transfe
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