Job Description
Job 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.
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nKey Responsibilities
nProvide QA oversight for biologics manufacturing operations including upstream,
ndownstream, and fill-finish processes.
nTo handle Training management, Document management and QMS.
nTo handle development quality assurance activities.
nEnsure compliance with cGMP, GLP, GDP, and regulatory guidelines.
nReview and approve batch manufacturing records (BMRs), SOPs, protocols, and reports.
nSupport technology transfer activities for biologics processes.
nManage deviation investigations, CAPA, change control, and risk assessments.
nEnsure accurate documentation practices (GDP).
nReview and approve validation protocols and reports (process, cleaning, equipment, method
nvalidation).




nCoordinate cross-functional activities with manufacturing, QC, regulatory affairs, and
nvalidation teams.
nProvide training on quality systems and regulatory requirements.
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nQualifications
nEducation:
nMaster’s degree in Biotechnology, Microbiology, Biochemistry, or related life sciences.
nExperience:
no Around 5 to 7 years of experience in Quality Assurance in biologics/biopharmaceutical
nindustry, with experience in biosimilars, biologics
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no Required Skills
nProcess development Quality assurance.
nHandling of equipment qualifications and process validations.
nFamiliarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10).
nStrong documentation review and quality systems management.
nHandling document management and training management.

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