Production Manager

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