- Ensures that all products are released to meet inventory requirements, GMP and BMS internal standards. Coordinates activities between release sites, Supply Chain and Regulatory Affairs to meet release deadlines. Determines the final disposition, reviews essential documentation and releases all NHP products/components distributed by MJN Canada.
- Builds alignment with internal and external departments, NAQA and NASC. Develops effective working relationships with peers at all product manufacturing and testing sites.
- Participates in a work environment consistent with BMS Core Behaviours with focus on personal accountability, prioritizing workload, meeting deadlines and owning business results.
- Manages the complaint processes and evaluates all complaints involving alleged quality issues or adverse reactions (Pharmacovigilance).
- Controls, maintains and administers the batch documentation review program. Requests and reviews batch documentation assuring compliance to GMP and BMS internal standards.
- Provides support for systems inquiries and product quality issue resolution. Notifies and follows up on all ambiguities, omissions or discrepancies with product sources.
- Manages QA activities within local manufacturing and distribution sites. Some travel will be required.
- Assures departmental SOP’s reflect current practices and are regularly revised to reflect new learning’s/processes and regulatory changes.
- Knowledge and understanding of GMP’s, applicable regulations, internal and corporate policies for the activities that are GMP regulated.
- Must be familiar with the processes related to the production, importation, and distribution of nutritional, Natural Health and pharmaceutical products.
- Knowledge and understanding of computerized Distribution System, computer software (Excel, Word, Netscape mail), and quality assurance control systems and processes.
- Experience in a team-oriented Quality Assurance organization. Experience in a Quality Control laboratory is an asset.
- Familiarization with manufacturing operations, enabling interaction with quality assurance, manufacturing, and inventory and distribution personnel to deliver value added results.
- Experience in making sound decisions and prioritizing workload to meet inventory requirements while operating within Quality Assurance policies and procedures.
- Demonstrated ability to effectively communicate ideas and accomplish challenging goals and objectives while working with others at multiple levels within an organization.
- Must possess at least a Health Sciences University Degree. Knowledge of Pharmacology or Microbiology would be an asset.