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