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Quality Assurance Senior Associate
3 months ago
Company Overview:
Natco Pharma (Canada) Inc. operates as the Canadian branch of Natco Pharma Limited, a fully integrated pharmaceutical entity dedicated to research and development alongside the production of medicinal products. We pride ourselves on being a reliable supplier of pharmaceuticals, as demonstrated through our collaborations with some of the largest pharmaceutical companies globally. Our reputation is built on trust, dependability, and a steadfast commitment to our clients.
Based in Mississauga, Natco Pharma (Canada) Inc. is bolstered by a robust, cross-functional team.
Position Summary:
We are seeking a Senior Associate in Quality Assurance to enhance our Quality Assurance division for a fixed-term contract.
Key Responsibilities:
- The Senior Quality Assurance Associate will independently manage essential quality functions, including product release, deviation oversight, and auditing processes. This role requires staying updated with regulatory standards and applying quality principles to ensure compliance with Good Manufacturing Practices (GMP) for all products distributed by Natco Pharma Canada. Responsibilities include:
- Drafting, reviewing, and overseeing compliance documentation such as deviations, Corrective and Preventive Actions (CAPA), product complaints, and change controls.
- Executing product release processes by evaluating all Master Production Documents, Batch-Specific Documents, and Quality Control samples while maintaining records in accordance with regulatory standards.
- Preparing and reviewing deviation reports from manufacturers for impact assessments and corrective actions, ensuring timely closure.
- Managing stability data for all finished products.
- Conducting audits of vendors and testing laboratories, followed by the preparation of audit reports.
- Approving master batch records and liaising with manufacturers to resolve discrepancies, including conducting necessary meetings.
- Writing and reviewing Standard Operating Procedures and overseeing employee training.
- Engaging with external partners, consultants, and suppliers to request and provide necessary data.
- Collaborating with team members to achieve collective goals while demonstrating strong support for Natco's core values.
- Performing additional tasks as assigned by the Director and other relevant responsibilities as designated by Natco Management.
- Possessing thorough knowledge of GMP, data integrity principles, and Food and Drug Regulations.
Qualifications:
- A degree from a Canadian university or an equivalent qualification in a science-related discipline.
- A minimum of four years of practical experience in Pharmaceutical Quality Control or Quality Assurance.
- In-depth understanding of Health Canada Food and Drugs regulations, GMP, GLP, ICH guidelines, and US FDA regulations.
- Proficiency in Microsoft Office applications.
Employment Type: Full-time, Fixed-term contract
Compensation: Starting from $60,000 per year
Work Schedule: Monday to Friday
Education Requirement: Bachelor's Degree (preferred)
Experience Requirement: Four years in Pharmaceutical Quality Control or Quality Assurance (preferred)
Work Location: In-person
