Supporting the Quality Systems required to ensure regulatory and GMP compliance obligations
Negotiates with external suppliers on the provisions of the customer Quality Agreements
Makes decisions in consultation with the Manager, External Quality on respective quality responsibilities
Responsible for ensuring that Quality Agreements are current for vendors supplying to multiple Apotex Manufacturing Sites
Liaise directly with Apotex Suppliers in negotiating Supplier Quality Agreements
Monitor and track status of Quality Agreements
Provides support to External Quality Managers in reviewing GMP Quality Documents
Reviews third party manufacturer’s Stability protocols and Summary Reports
Reviews and approves third party manufacturer’s Change Controls
Provides support to Customer Operations Manager

Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy or a related science
Must be familiar with overall pharmaceutical manufacturing and quality systems/process
Good knowledge of global GMPs and QA/QC systems associated with the manufacture of human drug products
Excellent written and verbal English communication skills
Excellent interpersonal skills and ability to relate well to internal and external customers
Minimum 8 years experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably with multiple dosage forms
Experience with international regulations (e.g. Health Canada, US FDA, EU) is an asset
Must be detail oriented, accurate and reliable
Excellent organization skills and analytical thinking

Assistant Manager – External Quality

Key skills