المسمى الوظيفي

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.

Manager - Production

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