Associate Ii, Quality Assurance

4 weeks ago

Mississauga, Canada Resilience Full time

JOB SUMMARY:
Ready to join a team dedicated to quality excellence, innovation and the advance of complex medicine manufacturing supporting patients worldwide? Are you an architect at heart and love designing and developing systems and processes from the ground up? We started an incredible journey and are looking for passionate leaders to join us on this important mission. The Quality Assurance (QA)Operations, Associate II is responsible for quality oversight of operations at the RESILIENCE Mississauga facility. The main role is to provide an independent oversight of operations, inclusive of the production areas, warehouse, and Quality Control laboratories, to ensure that day-to-day GMP activities are executed in a compliant manner to meet company’s procedures and policy and Regulatory requirements. The position is accountable to address QA activities relating to clinical and commercial manufacturing, and related issues which directly or indirectly impact product quality. It includes QA review and approval of Batch Records, Deviations, Laboratory Investigation, Environmental Monitoring Investigations, dispositions intermediates and Drug Substance, Change Control, and provides on the shop-floor presence. The incumbent provides timely risk-based decision making and proactive support with the focus on operational excellence and continuous improvements. This job reports to the Manager, QA Operations.

MAJOR RESPONSIBILITIES:
Production Support:

- Perform record review to ensure the compliance of manufacturing procedures to in-house specifications and government regulations on the manufacturing floor and ensuring on-the-floor presence of QA.
- Provide quality oversight on project teams and any necessary support to meet required project deadlines while ensuring compliance to internal SOPs and applicable regulatory guidelines.
- Support Quality Systems programs and processes which may include but is not limited to internal and external audits, inspections and release for materials and product, process product returns and complaints.
- Perform Aseptic Filling/ Manufacturing surveillance, check or audits on operations activities
- Review & approval of all process & product related documentation (SOPs, master batch records, protocols, reports, specifications, etc.).
- Review & approval of product & process related change controls (includes Supplier Change notifications & Technical Transfers).
- Review and Approval of Annual Product Review reports.
- Support the recall and product complaint management.
- Review Supplier Quality Agreements.
- Management of Client Quality Agreements.
- Collaborate with Operations teams to assist in implementing and maintaining effective, risk based GMP processes, procedures, and documentation.

Investigation Support:

- Review and approve investigation of deviations and associated CAPAs, Lab Investigations and Environmental Monitoring Reports by providing guidance and support to in root cause determination and reviewing the impact and criticality of the event with respect to product function, quality, effectiveness, safety, reliability, and customer satisfaction.
- Evaluate the appropriateness of the CAPA identified to address the root cause of the issue.
- Perform Quality and Compliance impact assessment of the event on products and processes.
- Review investigations for thoroughness and completeness and approve investigation reports.
- Perform trending of incidents and prepare monthly report for presentation to Senior Management during Quality Metrics/Quality Council Meetings.

Batch Review and Product Disposition:

- Review and approve Master Batch Documents (Batch Production Records (BPR), Buffer/Solution forms, and other documentation associated to batch manufacturing.
- Review executed batch records (BPR, Buffer/Solution forms, and other documentation associated to batch manufacturing), including equipment print outs, temperature charts, etc.
- Proactively perform follow up on outstanding issues to ensure timely disposition.
- Effectively disposition a batch ensuring compliance with regulatory and internal requirements.
- Material Review Board (QRB/MRB) process owner.
- Generate and approve RESILIENCE Certificate of Compliance.

ADDITIONAL RESPONSIBILITIES
- Perform deviation/non-conformance investigations, as required.
- Interface with client, as required.
- Collaborate and effectively communicate with internal customers, as necessary, to provide required documentation and/or resolve documentation or compliance issues.
- Assist with the GMP and procedural training program for department's new hires and current employees as required.
- Address gaps and perform revisions to departmental SOPs, forms, and processes to streamline systems and ensure compliance to GMP and related company and regulatory requirements.
- Provide proactive leadership in moving quality & compliance goals forward throughout the organization and achieving positive and value-added results.
- Performs all othe

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