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 guidelines and regulatory requirements
- Collaborate with cross-functional teams (Manufacturing, QA, QC, etc.) to drive compliance initiatives
Key Skills & Experience
- Hands-on experience in Drug Substance manufacturing (mAbs)Upstream (cell culture/bioreactors) and/or downstream (purification)
- Strong knowledge of:
- Deviations management
- Change control systems
- CAPA process
- Audit handling
- Experience in SOP and Batch Manufacturing Record (BMR) review/revision
- Familiarity with regulatory requirements (USFDA, EMA, MHRA, etc.)
- Good analytical, documentation, and communication skills
Educational Qualification
- B.Tech / M.Tech / MSc (Biotechnology, Biochemistry, Life Sciences, or related field)
