Assistant Manager - Quality

Role Overview: As a Quality Assurance Specialist at Apotex Inc., you will report to the General Manager, QA 3rd Party Ops, India, and play a crucial role in ensuring the quality systems required for Apotex Suppliers meet regulatory and GMP compliance obligations. Your responsibilities will involve negotiating Quality Agreements with external suppliers, monitoring the status of Quality Agreements, reviewing GMP Quality Documents, Stability protocols, and Change Controls of third-party manufacturers, and providing support for customer requests for products manufactured by Apotex for Third Parties. Your attention to detail, strong communication skills, and knowledge of pharmaceutical manufacturing and quality systems will be key in achieving the outcomes as part of a collaborative team effort. Key Responsibilities: - Negotiate Quality Agreements with external suppliers ensuring compliance to GMP standards and Apotex internal requirements - Ensure Quality Agreements are current for vendors supplying to Apotex Manufacturing Sites - Liaise with Apotex Suppliers to negotiate Supplier Quality Agreements and escalate issues to management when necessary - Monitor and track the status of Quality Agreements - Review GMP Quality Documents, Stability protocols, and Change Controls of third-party manufacturers - Provide support for customer requests related to products manufactured by Apotex for Third Parties - Perform all work in compliance with established regulatory and safety requirements, Code of Conduct, and Business Ethics - Operate in accordance with Apotex Corporate Values: Collaboration, Courage, Perseverance, and Passion - Fulfill any other relevant duties as assigned Qualification Required: - Minimum B.Sc. in Biology, Microbiology, Chemistry, Pharmacy, or a related science - Familiarity with pharmaceutical manufacturing and quality systems/process - Knowledge of global GMPs and QA/QC systems associated with human drug products - Excellent written and verbal English communication skills - Strong interpersonal skills and ability to effectively engage with internal and external stakeholders - Minimum 8 years of experience in the pharmaceutical industry with relevant QA/QC/Mfg experience, preferably across multiple dosage forms - Experience with international regulations (e.g., Health Canada, US FDA, EU) is an asset - Detail-oriented, accurate, and reliable with demonstrated personal leadership and accountability - Excellent organization skills and analytical thinking At Apotex, we are dedicated to creating an inclusive and accessible work environment where every employee is valued, respected, and supported. We also offer accommodation for applicants with disabilities as part of the recruitment process. If you require any accommodations during the interview or testing process, please inform us in advance to ensure a seamless experience.,