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).
 Solid documentation review and quality systems management.
 Handling document management and training management.

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