Reports To: Plant Head / General Manager - Operations / Managing Director
Supervises: Production Managers, Shift In-Charges, Operators and Technical Staff
Experience: 12-20 years in API or intermediates manufacturing with at least 5 years in a managerial or leadership role.
Position Summary:
The Production Head will be responsible for leading and managing all manufacturing operations for API intermediates ensuring production targets are met with high quality, cost-effectiveness, regulatory compliances and safety standards. This role will oversee process optimization, resource management and continuous improvement initiatives to drive operational excellence in a cGMP-regulated environment.
Key Responsibilities:
1. Production Management
Plan, organize, and oversee daily manufacturing operations of API intermediates.
Ensure achievement of production targets (yield, throughput, quality and cost).
Review production schedules, process orders, and manpower planning to optimize capacity utilization.
Ensure adherence to batch manufacturing records (BMRs) and standard operating procedures (SOPs).
Troubleshoot process deviations and equipment issues in coordination with engineering and quality teams.
Oversee raw material planning and management by coordinating with suppliers, production and procurement teams to maintain optimal stock levels and meet production demands.
2. Regulatory & Quality Compliance
Ensure full compliance with cGMP, ISO, EHS and other regulatory requirements (USFDA, EMA, WHO, etc.).
Collaborate with Quality Assurance (QA) and Quality Control (QC) to ensure consistent product quality.
Participate in internal and external audits (regulatory, customer or third-party).
Support validation activities (process validation, cleaning validation, equipment qualification).
3. Process Optimization & Technology Transfer
Lead process improvement, cost reduction and yield enhancement projects.
Coordinate with R&D / Technology Transfer teams for new product scale-up and commercialization.
Ensure smooth transfer of processes from lab scale to pilot and commercial production.
Implement Lean Manufacturing and Six Sigma initiatives.
4. People Management
Manage and mentor production teams, ensuring high performance and engagement.
Conduct training programs to enhance GMP awareness and technical competence.
Foster a culture of accountability, safety and continuous improvement.
5. Safety, Health and Environment (SHE)
Enforce strict adherence to safety norms and environmental regulations.
Implement and monitor process safety management (PSM) systems.
Lead incident investigations and implement corrective & preventive actions (CAPA).
6. Budgeting & Reporting
Prepare and manage annual production budgets and cost control measures.
Maintain production metrics, dashboards and management reports.
Collaborate with supply chain and maintenance teams for optimal resource planning.
Key Skills & Competencies:
Strong technical knowledge of API / chemical process manufacturing.
Sound understanding of cGMP, ICH Q7 and regulatory standards.
Expertise in batch operations, process engineering and equipment such as reactors, centrifuges, dryers etc.
Leadership, problem-solving and decision-making abilities.
Excellent communication and cross-functional collaboration skills.
Qualifications & Experience:
Education: B.Tech / M.Tech / M.Sc in Chemical Engineering, Chemistry or related field.
Experience: 12-20 years in API or intermediates manufacturing with at least 5 years in a managerial or leadership role.
Preferred Exposure: USFDA / EMEA / WHO-audited facilities, continuous improvement initiatives, and process scale-up.
Key Performance Indicators (KPIs):
Achievement of production and yield targets.
Compliance metrics (deviation, CAPA closure, audit findings).
Safety performance (zero accidents / incidents).
Cost reduction and process efficiency improvements.
Employee retention and training effectiveness.
About the Company:
Overview:
Nueve Healthcare is a leading manufacturer of Active Pharmaceutical Ingredients (APIs) and pharmaceutical intermediates committed to delivering high-quality products to the global pharmaceutical and biotechnology industries. Our state of the art manufacturing facility is dedicated to meeting the strictest regulatory standards while maintaining a focus on innovation, sustainability and customer satisfaction.
Strategically located on Delhi-Dehradun Expressway, within proximity of hubs for pharmaceuticals and biotechnology in Haridwar, Roorkee and Dehradun, providing access to skilled labour and logistics.
The facility spans over 150,000 square feet, featuring advanced manufacturing, research and development and quality control laboratories.
Currently with 1 dedicated plant for API manufacturing capacity of 144 KL and 1 for intermediates manufacturing capacity of 155 KL. There is a provision of 5 new plants with their supporting utilities and infrastructure within the existing premises.
Vision:
To be recognized as a leading manufacturer of high quality API's and intermediates, driving advancements in healthcare through quality, reliability and innovation.
Mission:
To manufacture high quality API's and intermediates that empowers our customers to develop effective and safe pharmaceutical products, while fostering a culture of safety, sustainability and continuous improvement.
Visit our website for more information: www.nuevehealthcare.com and share the updated CV to hr@nuevehealthcare.com
Job Types: Full-time, Permanent
Pay: From ?100,000.00 per month
Work Location: In person
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