Key skills
Critical Thinking
About this role
Role Overview
- 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.
Requirements
- 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
- Strong critical thinking skills
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
Benefits
- Health insurance
- Professional development opportunities