Senior Associate, Quality Assurance
1 month ago
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. Natco 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 a Senior Associate, Quality Assurance, to join our Quality Assurance team for a one-year contract.
Duties and responsibilities:
- The Senior Quality Assurance Associate is responsible for independently handling key quality functions such as product release, deviation management and audits. The responsibility of this role is also to stay current with all regulatory guidelines and apply the guiding quality principles to ensure GMP compliance of all products marketed by Natco Pharma Canada. Duties include:
- Writing, reviewing and managing Compliance elements such as deviation, CAPA, Product complaint and Change Controls.
- Independently perform the product release by reviewing all Master Production Documents, Batch Specific Documents, and QC samples and maintain records as per regulatory requirements.
- Write and Review deviation reports issued by fabricators for impact assessment, and corrective preventative actions and ensure they are closed within established timeframes.
- Manage Stability data of all finished product.
- Conduct vendor/testing lab audits and prepare audit reports.
- Approve master batch records and communicate with all fabricators to address any discrepancies and conduct meetings as necessary to resolve issues.
- Write and review Standard Operating Procedures, manage training of employees.
- Communicate with external sources such as partners, consultants, and suppliers to request and/or provide data.
- Work as a member of a team to achieve all outcomes. Demonstrate strong and visible support of Natco’s values.
- Perform additional duties as assigned by the Director and any other relevant jobs entrusted by Natco Management.
- Through knowledge of GMP and Data integrity principles and Food Drug Regulations.
Knowledge and skills:
- Canadian university degree or a degree recognized as equivalent by a Canadian university in a science-related field.
- Minimum of 4 years practical experience in Pharmaceutical Quality Control / Quality Assurance.
- Thorough knowledge of Health Canada Food and Drugs regulations, GMP, GLP, ICH guidelines, and US FDA guidelines.
- Proficiency with MS Office products.
If you are interested in joining our team, and meet the requirements for the position, please submit your resume to careers@natcopharma.ca using “Quality Assurance” 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.
Job Types: Full-time, Fixed term contract
Contract length: 12 months
Pay: From $60,000.00 per year
Schedule:
- Monday to Friday
Education:
- Bachelor's Degree (preferred)
Experience:
- Pharmaceutical Quality Control / Quality Assurance: 4 years (preferred)
Work Location: In person
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