North York, Ontario
Technical Quality Manager II (Engineering) SNFIJP00003051
Technical Manager- Product Quality
The position is responsible for Agency Lot Release Protocol preparation. This person's role is vital as independent quality review of critical manufacturing and test data to assure the consistent quality of each manufactured lot before it is submitted to Agencies
Lot Release Protocols (90%): Populate, review and publish
Lot Release Protocols for submission to regulatory agencies ensuring right first time accuracy throughout the process.
Support the preparation of responses to lot release queries from regulatory agencies in a timely manner.
Quality Systems & Projects (10%):
Maintain training to perform the designated cGMP activities and meet Health Safety and Environment requirements.
Support maintaining Quality Systems (e.g. deviation, CAPAs, change controls, audits and inspections).
Collaborate with sites and support projects that improve safety, quality, delivery, cost, involvement and strategic priorities. Support Quality Initiatives for process improvement.
An independent quality review of critical manufacturing and test data for each lot of vaccines is essential to assure the consistent quality of each manufactured lot before it is marketed. Escalation to Senior Management on quality events, resolution of conflicts and propose recommendations. Participation in self-inspections and Regulatory Inspections.