Associate Manager - Quality Assurance

Job Description:

Responsibilities

• 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. 

Qualification & Experience

• Qualification : B.Pharm /M. Pharm/M.Sc
• Experience : 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance /validations.