Job Summary Senior Executive QA – Biologics is responsible for overseeing quality assurance activities related to biologics, manufacturing, ensuring compliance with c GMP, regulatory guidelines (FDA, EMA, ICH), and company quality standards. Key Responsibilities Provide QA oversight for biologics manufacturing operations including upstream,downstream, and fill-finish processes. To handle Training management, Document management and QMS. To handle development quality assurance activities. Ensure compliance with c GMP, GLP, GDP, and regulatory guidelines. Review and approve batch manufacturing records (BMRs), SOPs, protocols, and reports. Support technology transfer activities for biologics processes. Manage deviation investigations, CAPA, change control, and risk assessments. Ensure accurate documentation practices (GDP). Review and approve validation protocols and reports (process, cleaning, equipment,



methodvalidation). Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, andvalidation teams. Provide training on quality systems and regulatory requirements. Qualifications Education: Master’s degree in Biotechnology, Microbiology, Biochemistry, or related life sciences. Experience:o Around 5 to 7 years of experience in Quality Assurance in biologics/biopharmaceuticalindustry, with experience in biosimilars, biologicso Required Skills Process development Quality assurance. Handling of equipment qualifications and process validations. Familiarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10). Solid documentation review and quality systems management. Handling document management and training management.

📌 Senior Executive Quality Assurance (Chhattisgarh)
🏢 MSN Laboratories
📍 Chhattisgarh