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