Manager - Production

About the Role

We are seeking an experienced Manager to join our Production team at the Pithampur Unit-3. Reporting to the Senior Manager / Plant Production Head, the ideal candidate will have a minimum of 15 years of experience in pharmaceutical manufacturing, particularly within regulatory-approved environments such as USFDA, MHRA, and EU. Specialization in Derma, Nasal, or Liquid Oral dosage forms is required.

Education and Eligibility

• B.Pharm or M.Pharm
• B.E. or B.Tech
• M.Sc. in Chemistry, Biotechnology, Pharmacy, or related fields

Key Responsibilities

• Oversee manufacturing and filling processes according to planned schedules.
• Meet production targets and ensure adherence to schedules.
• Optimize utilization of manpower, machinery, materials, and utilities.
• Operate and manage systems including SAP, Viva, eBMR/EBR, and PAS-X MES.
• Assure compliance with cGMP standards, Data Integrity, and regulatory guidelines.
• Maintain readiness for audits by USFDA, MHRA, EU, WHO, and others.
• Manage deviations, investigations, corrective actions (CAPA), and handle OOS/OOT and market complaints.
• Support validation, qualification, and technology transfer activities.
• Drive continuous improvement initiatives like Lean Manufacturing and Six Sigma to improve productivity, yields, and reduce cycle times.
• Manage costs related to manufacturing (COGM, CCPC) by implementing cost-saving projects and reducing waste.
• Ensure equipment reliability through preventive maintenance and breakdown management.
• Support automation, digitization efforts, and compliance with 21 CFR Part 11.
• Participate in expansion and modification projects of the facility.
• Promote a safety-first culture with zero-accident goals by conducting risk assessments and incident investigations.
• Lead safety observations and corrective measures.
• Foster a high-performance team environment by providing training, coaching, and conducting Gemba walks.
• Manage team performance, engagement levels, and succession planning.

Major Performance Indicators

• Achieve zero lost time accidents and timely closure of safety observations.
• Maintain high quality through Right First Time production, deviation reduction, CAPA closures, and audit management.
• Ensure timely schedule adherence and batch release metrics.
• Reduce cost of goods manufactured (COGM) and cost per cost center (CCPC).
• Improve overall equipment effectiveness (OEE), throughput, and cycle times.
• Maintain training compliance and control employee attrition rates.

Required Technical Skills

• Expertise in cGMP and regulatory compliance.
• Skills in investigations and corrective/preventive actions.
• Experience with validation and qualification procedures.
• Knowledge of Lean Manufacturing and operational excellence methodologies.
• Understanding of data integrity and 21 CFR Part 11 requirements.
• Risk management capabilities.

Behavioral Competencies

• Strong leadership and team-building abilities.
• Effective decision-making and problem-solving skills.
• Excellent stakeholder management and communication competencies.
• Commitment to continuous improvement mindset.