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Assistant Manager – External Quality
Apotex Inc.Assistant Manager handling external quality compliance and supporting Quality Systems at Apotex. Responsible for supplier negotiations and compliance with GMP and regulatory standards in the pharmaceutical industry.
About the role
Key responsibilities & impact- 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
Requirements
What you’ll need- 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
Benefits
Comp & perks- Accommodation for applicants with disabilities
- Supportive work environment
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP complianceQuality AgreementsGMP Quality DocumentsStability protocolsChange ControlsQA/QC systemspharmaceutical manufacturinganalytical thinkingdetail orientedaccuracy
Soft Skills
written communicationverbal communicationinterpersonal skillsorganizational skillsreliability
Certifications
B.Sc. in BiologyB.Sc. in MicrobiologyB.Sc. in ChemistryB.Sc. in Pharmacy