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SalaryBIOVECTRA Inc. has an immediate opening for a Manager Quality Assurance Biologics. This is a full-time permanent position located in Windsor, NS.
The candidate will be responsible for:
- Providing guidance and oversight to a team of employees. Responsible for basic Human Resources services for the team including payroll, review, and approval of vacation requests, providing employee feedback and evaluation where needed, and ensuring employees are in compliance with workplace rules.
- 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.
- Preparing, reviewing, and approving of controlled documents.
- Assessing gaps in the Quality System and its application, and introducing remediation e.g., use of risk assessment, root cause analysis, risk analysis tools and appropriate CAPA implementation.
- 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 BIOEVCTRA facilities.
- Additional duties assigned, based on business needs and the department supervisor’s request.
The successful candidate for this position should have:
- 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.
BIOVECTRA offers a competitive salary and benefit package.
