Senior Quality Assurance Manager

You will be joining Shalina Healthcare, a leading pharmaceutical company in sub-Saharan Africa with a mission to provide quality medicines to those in need. As a Senior Manager CQA based in Pawane, Navi Mumbai, India, you will report to the Head of Quality and play a crucial role in ensuring GMP compliance and overall performance of manufacturing and testing facilities. **Key Responsibilities:** - Prepare and adhere to annual planner for Quality audits for Loan licence Units (LLU), Third Party Manufacturing, and Shalina Operating units (OUs) to ensure GMP and GDP compliance. - Plan audits, review outcomes, and prepare audit reports, coordinating with vendors for compliance. - Initiate actions based on audit findings, conduct self-inspections, and ensure all-time audit readiness of Shalina laboratories sites. - Coordinate technical document evaluation, vendor management, and QMS implementation. - Present monthly quality review meetings and conduct training on quality aspects and GMP requirements. - Support cross-functional teams and handle any other specific work assigned by the Global Head of Quality. **Qualifications Required:** - 12+ years of experience in Quality - Qualification: B. Pharmacy or M. Pharmacy Or any science graduate with relevant experience - Thorough knowledge of shop floor of OSD, External, Oral Liquid & Sterile formulations Handling of contract manufacturing Sites **Competencies:** - Good exposure to GMP environment and regulatory inspections - Flexibility for business travel across India & Overseas Locations - Independent decision-making ability - Cross-functional working and effective communication skills with external stakeholders Join Shalina Healthcare to be part of a dynamic team working towards becoming the health champion of Sub-Saharan Africa by 2030. Your role as a Senior Manager CQA will contribute significantly to ensuring quality compliance and driving the company's mission forward. You will be joining Shalina Healthcare, a leading pharmaceutical company in sub-Saharan Africa with a mission to provide quality medicines to those in need. As a Senior Manager CQA based in Pawane, Navi Mumbai, India, you will report to the Head of Quality and play a crucial role in ensuring GMP compliance and overall performance of manufacturing and testing facilities. **Key Responsibilities:** - Prepare and adhere to annual planner for Quality audits for Loan licence Units (LLU), Third Party Manufacturing, and Shalina Operating units (OUs) to ensure GMP and GDP compliance. - Plan audits, review outcomes, and prepare audit reports, coordinating with vendors for compliance. - Initiate actions based on audit findings, conduct self-inspections, and ensure all-time audit readiness of Shalina laboratories sites. - Coordinate technical document evaluation, vendor management, and QMS implementation. - Present monthly quality review meetings and conduct training on quality aspects and GMP requirements. - Support cross-functional teams and handle any other specific work assigned by the Global Head of Quality. **Qualifications Required:** - 12+ years of experience in Quality - Qualification: B. Pharmacy or M. Pharmacy Or any science graduate with relevant experience - Thorough knowledge of shop floor of OSD, External, Oral Liquid & Sterile formulations Handling of contract manufacturing Sites **Competencies:** - Good exposure to GMP environment and regulatory inspections - Flexibility for business travel across India & Overseas Locations - Independent decision-making ability - Cross-functional working and effective communication skills with external stakeholders Join Shalina Healthcare to be part of a dynamic team working towards becoming the health champion of Sub-Saharan Africa by 2030. Your role as a Senior Manager CQA will contribute significantly to ensuring quality compliance and driving the company's mission forward.