Job Description
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.