Corporate Quality Assurance Jobs at JAMP group

The JAMP group is a proud Canadian owned company with its international headquarters located in Boucherville, 20 minutes from downtown Montreal, Quebec, Canada. The JAMP Pharma Group is active in all sectors of the pharmaceutical industry with our JAMP Pharma Generics, Orimed branded products, our Wampole and Laboratoire Suisse natural health supplements and our Cosmetic Import beauty and personal care products. The JAMP Pharma Group has also made a major investment in biosimilars which is one of the fastest growing markets in the pharmaceutical industry.

Post : Corporate Quality Assurance - Senior Executive / Assistant Manager

Key Responsibilities
• Risk Assessment & Reporting
o Conduct comprehensive nitrosamine and elemental impurities risk assessments for new products, technology transfers, and commercial products life-cycle changes.
o Prepare robust, scientifically sound assessment reports aligned with regulatory expectations and internal quality systems.

• Cross-Functional & Partner Collaboration
o Collaborate with internal teams and external stakeholders to compile, review, and finalize risk assessment reports.
o Serve as a technical point of contact, ensuring timely and accurate resolution of queries related to nitrosamine and elemental impurity evaluations.

• Analytical Method Development & Testing Oversight
o Coordinate with external laboratories and partners on analytical method development, validation, and confirmatory testing for nitrosamine impurities.
o Critically review AMV protocols/reports, CoAs, and analytical test results to support comprehensive impurity risk evaluations.

• Regulatory & Data Support
o Collect, trend, and interpret nitrosamine impurity data to support mitigation strategies and global regulatory submissions.
o Provide technically sound input for regulatory submissions and support in responses to nitrosamine impurity-related regulatory agency queries.

• Investigations
o Lead OOS, above Acceptable Intake (AI) investigations as well as deviation investigations related to nitrosamine impurities using structured root-cause analysis and CAPA development.
• Change Impact Assessments
o Evaluate manufacturing process changes, material/supplier changes, and other modifications to determine impact on nitrosamine and elemental impurity risk profiles and assessment reports.

• Quality, Compliance & Continuous Improvement
o Represents CQA (Scientific Affairs) function in meetings with internal/external stake holders.
o Drive continuous improvement initiatives to strengthen impurity control strategies and product quality.
o Ensure compliance with quality agreements and promote strong adherence to GMP across the organization.

Candidate Profile
Department : Corporate Quality Assurance
Experience : 5- 10 Years
Qualification : B.Pharma / M.Pharma / M.Sc
Location : Ahmedabad