Quality Assurance Data Reviewer

2 weeks ago

Windsor, Canada BioVectra Inc. Full time

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.

**BIOVECTRA** has an opening for a **Quality Assurance Data Reviewer.** This is a permanent, full-time position located in** Windsor, NS**
- Supporting the incident programs (deviation, laboratory investigation, complaint, supplier etc), including reviewing, assessing the severity and approving minor incidents and outcomes of Phase 1 OOS investigations and participating in the investigations of major incidents.
- Participating in the internal audit program and supporting external audit requirements.
- Managing and leading changes to SOPs and supporting changes to SOPs made by other departments through the change control review process.
- Supporting the APR Program, Metrics and Scorecards Reporting Program, including QSR.
- Monitoring and enforcement of GMP requirements during day to day operations for all departments within the company.
- Supporting the supplier management program.
- Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.
- Preparing or assisting in the preparation of reports and protocols, including validation and qualification.
- Issuing, checking, and archiving QC notebooks.
- Providing GMP and SOP training to various departments.
- Managing product label masters and creation.
- Supporting the CAPA program.
- Supporting Analytical validation and process transfer activities, and the overall method and Analytical process lifecycle by reviewing and approving analytical validation data and revising, reviewing and approving protocols, reports and work instructions as needed.
- Participating in the Pest Control program, including inspection and investigation.
- Performing batch record review and data review for release of critical raw materials, active pharmaceutical ingredients, and final products.
- Supporting Process lifecycle by reviewing and approving creation and changes to batch records.
- Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes.
- Adhering to BIOVECTRA's Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
- Additional duties assigned, based on business needs and the department supervisor's request.
- Post-Secondary Education.
- Bachelor's degree in a scientific field an asset.
- Three years of work experience with a food or drug manufacturing company, with
- One year direct experience in a Quality Unit position.

**Closing Date: May 5, 2023

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