Website JAMP Pharma ltd
Post Name: 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
