Manager - Production API

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Division

Piramal Critical Care

Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.

PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.

PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.

For more details, please visit https://www.piramalcriticalcare.com/global/

Job Title

Manager - Production ( API )

Job Description

To be responsible for the overall activities of plant.

To be responsible for the production and manpower planning of plant.

To ensure that products are produced and stored according to the appropriate procedures & documentation in order to obtain/maintain the required quality.

To review & ensure the batch production records (BMR & BPR etc.) are executed as per standards.

Job Summary:**

Piramal Pharma Limited is seeking a highly motivated and experienced Production Manager to oversee the Active Pharmaceutical Ingredient (API) manufacturing operations. This role is crucial for ensuring efficient production, maintaining high quality standards, and adhering to all regulatory guidelines within our state-of-the-art facilities. The Manager will lead a team, optimize processes, and contribute to the continuous improvement of our API production capabilities.

Job Responsibilities:**

• Manage and supervise all aspects of API production, including planning, scheduling, execution, and monitoring to meet production targets and deadlines.
• Ensure compliance with Good Manufacturing Practices (GMP), EHS (Environment, Health, and Safety) regulations, and all relevant quality standards (e.g., ICH guidelines, regulatory body requirements).
• Lead and mentor a team of production supervisors, operators, and technicians, fostering a culture of safety, quality, and continuous improvement.
• Optimize production processes for efficiency, yield, and cost-effectiveness through process analysis, troubleshooting, and implementation of best practices.
• Collaborate with cross-functional teams including Quality Assurance, Quality Control, Engineering, and Supply Chain to ensure seamless operations and timely resolution of issues.
• Develop and implement production plans, standard operating procedures (SOPs), and batch manufacturing records (BMRs).
• Monitor key performance indicators (KPIs) and generate reports on production output, quality metrics, and resource utilization.
• Identify and implement corrective and preventive actions (CAPAs) for deviations and non-conformances.
• Participate in internal and external audits and inspections, ensuring audit readiness at all times.
• Manage inventory of raw materials, intermediates, and finished goods within the production area.
• Oversee equipment maintenance and calibration schedules to ensure optimal functioning and prevent downtime.
• Drive continuous improvement initiatives through lean manufacturing principles and Six Sigma methodologies.
  
  

• Bachelors or Masters degree in Chemical Engineering, Pharmacy, Chemistry, or a related scientific discipline.
• Minimum of 8-12 years of progressive experience in API manufacturing, with at least 3-5 years in a managerial or supervisory role.
• In-depth knowledge of cGMP regulations, EHS guidelines, and quality systems applicable to pharmaceutical API production.
• Proven track record of successful production management, process optimization, and team leadership.
• Strong understanding of chemical synthesis, reaction kinetics, and unit operations relevant to API manufacturing.
• Excellent problem-solving, analytical, and decision-making skills.
• Proficiency in using manufacturing execution systems (MES) and enterprise resource planning (ERP) software.
• Strong communication (written and verbal), interpersonal, and presentation skills.
• Ability to work effectively in a fast-paced, dynamic, and highly regulated environment.