Opportunity Description
Job Title: Executive / Senior Executive – Manufacturing Compliance (DS mAbs) Department: Manufacturing Compliance Experience: 3–10 Years Location: Bangalore Role Overview We are looking for a skilled professional in Manufacturing Compliance with experience in Drug Substance (mAbs – upstream and/or downstream). The role involves handling quality and compliance activities including deviations, change controls, CAPA, audits, and documentation to ensure regulatory compliance. Key Responsibilities Manage and investigate deviations , ensuring timely closure with proper root cause analysis Handle Change Control Management including initiation, assessment, and implementation Lead and track CAPA (Corrective and Preventive Actions) for effectiveness and compliance Participate in and support internal and external audits , ensuring readiness and closure of audit observations Review and revise SOPs and BMRs to maintain compliance with regulatory and internal standards Ensure adherence to cGMP guide...
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