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Tier-1 employer but niche sterile-injectable QA and on-premise reduces applicant density.
High—pharmaceutical sterile-injectable validation and regulatory skills are industry-specific and less transferable.
Explicit 6–7 years plus mandatory sterile injectable validation and cGMP requirements enforce strict filtering.
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Evaluate and review commercial drug batches and technology transfers to ensure compliance with specifications and regulatory expectations.
Manage New Product Introduction (NPI) projects including review and approval of validation protocols, risk management, and related documentation.
Investigate deviations, approve change controls, and ensure compliance with cGMP and global regulatory standards through quality review and oversight of site documentation.
Qualification: B.Pharm / M.Pharm / M.Sc.
6 to 7 years of experience in sterile injectable technology transfers, quality assurance, or validations.
Strong knowledge of current Good Manufacturing Practices (cGMP) and relevant GxP regulations.
Work Location: On Premise.
Experienced in managing end-to-end sterile injectable technology transfer and quality assurance processes within regulated environments.
Capable of independently assessing change controls and deviations with focus on compliance and operational impact.
Proficient in documentation review and approval to meet stringent global regulatory and quality standards.