Manager Quality Assurance Biologics
7 days ago
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 Inc. has an immediate opening for a
Manager Quality Assurance Biologics. This is a full-time permanent position located in
Windsor, NS.
- Managing a team of Quality Assurance specialists, including providing professional development and performance feedback.
- Allocating resources and coordinating with stakeholders across the Quality Unit and the company to ensure that batch record and data review due dates are set appropriately and are met.
- Managing and approving change controls, deviation investigations and lab incidents pertaining to Operations.
- Demonstrating the ability to understand complex quality issues and drive scientifically sound and compliant resolutions.
- Managing and trending analytical, production and stability data to observe trends and resolve issues.
- Overseeing regulatory actions and recalls related to the product.
- Preparing, reviewing and approving of controlled documents.
- Overseeing and participating in the preparation of annual product reviews.
- Ensuring continuous improvement, harmonizing QA and Compliance systems, and strengthening quality awareness.
- Providing quality oversight and guidance ensuring required Quality and compliance standards are met.
- Building and maintaining close communication with clients on quality items including: change management, investigations, master documents, CAPA and annual product review
- Participating in audit readiness programs and in client and regulatory inspections of BioVectra facilities.
- 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.
- Bachelor of Science.
- Five years of experience in Quality Assurance working in pharmaceutical and/or biotech.
- Experience in the design and implementation of quality management systems and continuous improvement.
- Knowledge of cGMPs, FDA and Health Canada pharmaceutical regulations for API's.
- Experience with Regulatory Agencies.
- Experience working in a pharmaceutical laboratory setting.
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Manager Quality Assurance Biologics
7 days ago
Windsor, Ontario, Canada BioVectra Inc. Full timeBIOVECTRA 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 Inc. has an immediate opening for aManager Quality Assurance Biologics. This is a full-time permanent position located...
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