Job Description

Job Summary

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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.

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Key Responsibilities

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 Provide QA oversight for biologics manufacturing operations including upstream,

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downstream, and fill-finish processes.

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 To handle Training management, Document management and QMS.

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 To handle development quality assurance activities.

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 Ensure compliance with cGMP, GLP, GDP, and regulatory guidelines.

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 Review and approve batch manufacturing records (BMRs), SOPs, protocols, and reports.

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 Support technology transfer activities for biologics processes.

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 Manage deviation investigations, CAPA, change control, and risk assessments.

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 Ensure accurate documentation practices (GDP).

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 Review and approve validation protocols and reports (process, cleaning, equipment, method

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validation).

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 Coordinate cross-functional activities with manufacturing, QC, regulatory affairs, and

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validation teams.

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 Provide training on quality systems and regulatory requirements.

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Qualifications

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 Education:

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Master's degree in Biotechnology, Microbiology, Biochemistry, or related life sciences.

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 Experience:

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o Around 5 to 7 years of experience in Quality Assurance in biologics/biopharmaceutical

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industry, with experience in biosimilars, biologics

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o Required Skills

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 Process development Quality assurance.

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 Handling of equipment qualifications and process validations.

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 Familiarity with regulatory guidelines (FDA, EMA, ICH Q7, Q8, Q9, Q10).

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 Solid documentation review and quality systems management.

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 Handling document management and training management.

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