Assistant General Manager Production

Assistant General Manager - Production

Production

Site Head

Luna, Padra

Position Summary:

cytotoxic product, equipment, isolators, HVAC systems with BIBO (Bag-In Bag-Out), wet scrubbers, OEL (Occupational Exposure Limit) studies

Key Responsibilities:

• Lead the overall manufacturing function for API operations, ensuring smooth plant operations and regulatory compliance
• Maintaining operation budget and operational norms in plant
• To ensure implementation of Quality and EHS policies in the Plant
• To ensure compliance to cGMP. GLP, GEP and EHS procedures and continually improve it
• To ensure that all the proposed changes in the product, process or equipment are evaluated before implementation and timely completion of qualification and validations.
• Ensure and facilitate the production planning and execution in line with supply chain and manufacturing team as per market requirement.
• Introduction and scale up of technology transfer. (New Prod) Constantly monitoring and improvement of product process, efficiency, services etc.
• Documentation work, Monthly Report, data preparation (Process trend analysis) and root cause analysis.
• Ensure the availability of consumable items & Planning of RM require as per campaign basis.
• Ensure the documents related to process cleaning / House Keeping.
• Control on fresh as well as recovered solvents/ spent solvent.
• Ensure the solid and process waste transfer to respective area and record maintaining.
• Other activities entrusted from time to time. Review the prepared/ Revision of BMR and SOP.
• Ensure Preventive Maintenance of Plant Equipment's in time frame.
• Ensure the training to subordinates.

Regulatory Compliance & Audit Readiness:

• Ensure the production function complies with USFDA, EU GMP, MHRA, and other global regulatory standards.
• Play a key role in handling USFDA and other regulatory audits as the Production Head, ensuring all compliance requirements are met.
• Maintain audit readiness by implementing best practices in Online Documentation, equipment qualification, validation, and plant upkeep.

Safety, Environment & Compliance:

• Ensure adherence to HSE (Health, Safety & Environment) policies and drive a culture of safety in all production operations.
• Monitor environmental compliance, including effluent treatment, hazardous waste management, and containment system validations as per local and international guidelines.
• Ensure all containment design and maintenance protocols adhere to industry best practices to minimize occupational exposure risks.

Team Leadership & Development:

• Build and lead a high-performing production team, ensuring continuous skill development and performance management.
• Foster a culture of innovation, accountability and operational excellence within the function.
• Train teams on cytotoxic product handling, isolator operation and containment best practices to enhance technical expertise.

Qualifications and Experience:

• B.E. / B. Tech Chemical, or MSc in Organic Chemistry.
• Minimum 15+ years of experience in the pharmaceutical industry, specifically in API manufacturing facilities.
• Must have experience handling USFDA, EU GMP, and other international regulatory audits.
• Audit Readiness & Compliance: Zero critical observations in regulatory audits.
• Operational Efficiency: Reduction in downtime and improvement in overall equipment efficiency (OEE).
• Project Execution: Timely completion of CAPEX projects within budget.
• Energy & Cost Optimization: Implementation of cost-saving and energy-efficient initiatives.
• Safety & Environmental Compliance: Adherence to HSE standards with zero safety incidents.
• Containment System Effectiveness: Compliance with OEL limits and optimal performance of BIBO, isolators and wet scrubbers.