01 Aug
|
Lupin India
|
Indore
01 Aug
Lupin India
Indore
Job Description Role: Manager (M2) - Production
n Location: Pithampur Unit-3
n Reports To: Senior Manager / Plant Production Head
n Experience Required: Min 15 years in Pharmaceutical manufacturing with exposure to regulatory-approved facilities (USFDA, MHRA, EU, etc.).
n Specialization: Derma, Nasal, Liquid Oral dosage forms
n Education:
n n B.Pharm / M.Pharm
n B.E. / B.Tech
n M.Sc. (Chemistry, Biotechnology, Pharmacy, or related disciplines)
n n Key Expectations
n Production Management
n n Execute manufacturing and filling activities as per plan.
n Achieve production targets and schedule adherence.
n Ensure optimum utilization of manpower, equipment, materials, and utilities.
n Handle SAP, Viva, eBMR/EBR, and PAS-X MES systems.
n n Quality & Compliance
n n Ensure compliance with cGMP, Data Integrity, and regulatory requirements.
n Maintain audit readiness for USFDA, MHRA, EU, WHO, etc.
n Manage deviations, investigations, CAPA, OOS/OOT, and market complaints.
n Support validation, qualification, and technology transfer activities.
n n Operational Excellence
n n Improve productivity, yield, and cycle times.
n Drive Lean Manufacturing and Six Sigma initiatives.
n Reduce manufacturing costs (COGM, CCPC).
n Lead waste reduction and process optimization projects.
n n Equipment & Facility Management
n n Ensure equipment reliability and uptime.
n Coordinate preventive maintenance and breakdown management.
n Support automation, digitization, and 21 CFR Part 11 compliance.
n Participate in expansion and modification projects.
n n Safety & EHS
n n Promote zero-accident culture.
n Conduct risk assessments and incident investigations.
n Drive safety observations and corrective actions.
n n People Leadership
n n Develop production teams through training and coaching.
n Conduct Gemba, SOP, and capability-building sessions.
n Manage performance, engagement, and succession planning.
n n Major KPIs
n Safety
n n Zero Lost Time Accidents (LTA)
n Near-miss reporting and closure
n Safety observation closure rate
n n Quality
n n Right First Time (RFT)
n Deviation reduction
n CAPA closure compliance
n Audit observation management
n n Delivery
n n Schedule adherence
n OTIF manufacturing performance
n Batch release support timelines
n n Cost
n n COGM reduction
n CCPC reduction
n Yield improvement
n Cost-saving projects
n n Productivity
n n OEE improvement
n Throughput enhancement
n Cycle time reduction
n Capacity utilization
n n People
n n Training compliance
n Attrition control
n Succession readiness
n Employee engagement
n n Technical Competencies
n n cGMP & Regulatory Compliance
n Investigation & CAPA
n Validation & Qualification
n Lean Manufacturing & Operational Excellence
n Data Integrity & 21 CFR Part 11
n Risk Management
n n Behavioral Competencies
n n Leadership & Team Building
n Decision Making
n Problem Solving
n Stakeholder Management
n Communication Skills
n Continuous Improvement Mindset
n
📌 Production Manager (Indore)
🏢 Lupin India
📍 Indore