Job DescriptionJob Summary
nSenior 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.
nKey Responsibilities
n Provide QA oversight for biologics manufacturing operations including upstream,
ndownstream, and fill-finish processes.
n To handle Training management, Document management and QMS.
n To handle development quality assurance activities.
n Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines.
n Review and approve batch manufacturing records (BMRs), SOPs, protocols, and reports.
n Support technology transfer activities for biologics processes.
n Manage deviation investigations, CAPA, change control, and risk assessments.
n Ensure accurate documentation practices (GDP).
n Review and approve validation protocols and reports (process, cleaning, equipment, method
nvalidation).




n Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, and
nvalidation teams.
n Provide training on quality systems and regulatory requirements.
nQualifications
n Education:
nMaster's degree in Biotechnology, Microbiology, Biochemistry, or related life sciences.
n Experience:
no Around 5 to 7 years of experience in Quality Assurance in biologics/biopharmaceutical
nindustry, with experience in biosimilars, biologics
no Required Skills
n Process development Quality assurance.
n Handling of equipment qualifications and process validations.
n Familiarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10).
n Solid documentation review and quality systems management.
n Handling document management and training management.

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