We are currently seeking a Group Lead, Quality Assurance to join our team at Teva Canada!
Tasks and responsibilities include:
Directly supervise and coordinate the activities of Third Party Quality Assurance associates ensuring a high standard of their performance and efficiency by scheduling work in accordance with established priorities and time lines.
Facilitate communication with external suppliers, external customers, supply chain, quality control, regulatory affairs, technical operations, shipping, packaging and other departments to gather information and resolve quality issues.
Ensure external suppliers adhere to GMPs and Quality agreements by providing oversight of activities associated with the manufacture, packaging and testing of bulk & finished products, including approval of related GMP documentation.
Ensure thorough deviation & complaint investigations by providing leadership, technical expertise and support to the staff in developing additional investigation and review skills.
Ensure staff are trained in applicable GMP/cGMP and SOPs on an ongoing basis. Provide guidance to the staff in properly interpreting these procedures.
Oversee the change control, deviation, complaint & CAPA quality systems including ensuring adequate & timely closure of records as well as implementation and verification of proposed corrective actions.
Perform ongoing staff performance assessments (PMPs) and make recommendations for promotion, salary revision, corrective action, and professional development.
Participate in Quality audits by Regulatory authorities – Health Canada, US-FDA, etc. – and Teva Global / private label customer, as required.
Perform other related duties as assigned
Must have a University degree in Chemistry, Pharmacy or a related Science from a recognized Canadian institution, or accredited as equivalent.
Minimum (5) five years’ experience in Quality Assurance, Quality Control, Technical Services, and/or Production in the pharmaceutical industry.
3 years supervisory experience in Quality Control, Quality Assurance, Product Development or Production or a proven track record within pharmaceutical or a related industry is a strong asset.
Excellent working knowledge of TrackWise, Oracle, LIMS, Smart QA, MS Office suite (Excel and Word)
Strong understanding of SOPs, GMPs, and cGMP’s applicable to Quality Operations, Manufacturing and Packaging
Strong communication skills, planning and organization skills, analytical and problem solving skills.
Manufacturing Quality Assurance
Manager, Quality Assurance
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