Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of drug products. We are a trusted supplier of medicines evidenced from our work with the world’s largest drug companies. atco is renowned for trust, reliability, and commitment to our customers.
Natco Pharma (Canada) Inc. is headquartered in Mississauga and is supported by a strong cross-functional team.
We are currently looking for an experienced quality professional to join our Quality Assurance and Pharmacovigilance team.
Duties and Responsibilities:
The Senior Associate, Quality Assurance supports and maintains Natco Canada’s Quality Management System to ensure ongoing compliance with Health Canada’s Good Manufacturing Practices (GMP), Good Pharmacovigilance Practices (GVP), applicable regulations, and internal quality standards. This role works cross-functionally with internal teams, third-party service providers, and external partners to support quality operations, complaint handling, deviations, change controls, and batch disposition activities.
- Intake and process medical inquiries and product quality complaints in accordance with applicable Standard Operating Procedures (SOPs).
- Maintain Quality Management System (QMS) logs related to deviations, CAPAs, change controls, product complaints, and associated extensions to ensure timely completion of assigned tasks.
- Perform independent review of finished product QA samples, receiving documentation, and Certificates of Analysis (CoAs) for APIs, excipients, packaging components, and finished goods to support batch disposition activities, as required.
- Review stability data and coordinate follow-up activities as necessary.
- Coordinate with internal teams, including Quality Assurance and Sales Operations, as well as Natco Canada’s warehouse, to evaluate returned goods and expired inventory for appropriate disposition in accordance with established SOPs.
- Support customer and regulatory inspections related to Pharmacovigilance (PV) and GMP activities.
- Initiate Change Controls as required and coordinate documentation collection and organization to support timely closure.
- Initiate Deviation Reports as applicable and ensure investigations and closures are completed within established timelines.
- Communicate with external stakeholders, including partners, consultants, suppliers, and third-party service providers, to obtain and provide quality-related information and documentation.
- Participate in team meetings and routine touchpoint meetings with internal and external stakeholders.
- Contribute to a collaborative team environment and demonstrate strong commitment to Natco Canada’s quality culture, values, and compliance standards.
- Perform additional duties and responsibilities as assigned by management or the Director, Quality Assurance & Pharmacovigilance.
Education and Experience:
- Bachelor’s degree in a science-related field or recognized equivalent.
- Post-graduate certificate in Quality Assurance and Regulatory Affairs, or other continuous learning certificates in quality assurance is considered an asset.
- Minimum 5 years of Quality Assurance experience within a pharmaceutical company.
- Experience working with electronic Quality Management Systems (eQMS).
- Proficiency with Microsoft Office applications.
Working knowledge of:
- Health Canada Food and Drugs Act and Regulations
- GMP requirements
- ICH guidelines
Additional Requirements:
- Ability to manage multiple priorities in a fast-paced environment and effectively manage competing deadlines.
- Strong attention to detail, organizational skills, and commitment to accuracy and transparency.
- Maintain professional interactions with internal and external stakeholders while adhering to Natco Canada’s quality standards.
- Build strong working relationships through effective communication, collaboration, and responsiveness.
Working Environment:
- Hybrid work environment consisting of both in-office and remote work arrangements.
- General office setting with the ability to work independently with minimal supervision.
If you are interested in joining our team, and meet the requirements for the position, please submit your resume to [email protected] using “Senior Associate, QA” in the subject line.
We thank all applicants for their interest in Natco Pharma (Canada) Inc., but only candidates selected for interviews will be contacted. Applications from recruiters or employment agencies will not be considered without a signed services agreement.
Pay: From $65,000.00 per year
Benefits:
- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care
Application question(s):
- Rate your knowledge of Health Canada Food and Drugs Act and Regulations:
A: Fair B: Good C: Excellent
Education:
- Bachelor's Degree (preferred)
Experience:
- eQMS: 2 years (required)
- Pharmaceutical Quality Assurance: 5 years (required)
Work Location: Hybrid remote in Mississauga, ON L5N 2R7
