Associate Manager - Quality Assurance

Pfizer•Ottawa, ON

3d•Onsite

About The Position

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. Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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
Proactive approach to problem-solving

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.