Senior Executive Quality Assurance

Job Summary Senior Executive QA – Biologics is responsible for overseeing quality assurance activities related to biologics, manufacturing, ensuring compliance with cGMP, 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 cGMP, 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, method validation).  Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, and validation 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/biopharmaceutical industry, with experience in biosimilars, biologics o Required Skills  Process development Quality assurance.  Handling of equipment qualifications and process validations.  Familiarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10).  Strong documentation review and quality systems management.  Handling document management and training management.