Job Description

Purpose of the Role:-

To lead API manufacturing operations through effective supervision and team management, ensuring sustainable operational performance, production targets are achieved safely, efficiently, and in compliance with cGMP, regulatory requirements and business objectives. In addition to this, strengthening quality culture through robust implementation of GMP, quality systems, process standardization, data integrity, and continuous improvement programs.

Key Individual Accountabilities:-

· Production management: Plan, organize, and control API manufacturing activities. Optimize plant capacity utilization,

Monitor batch execution, Yield, Cycle time, and resource utilization.

· Participate, support & timely Closure of deviation, customer complaints, change control and Audit compliance actions.

· Maintain audit readiness at all times and adherence to SOPs, BPRs, and quality systems.

· Identify improvement ideas from Daily cycle to improve efficiency & productivity.

· Supervise manufacturing activities throughout the production process equipment and monitor process parameters.

· Facilitate root cause analysis & problem-solving initiatives to address quality & operational issues.

· Ensure compliance with GMP, regulatory requirements, corporate standards, and customer expectations.

· Collaborate with QA, QC, Engineering, EHS, Warehouse, Supply Chain, Procurement RA & Finance.

· Drive Lean Manufacturing, Six Sigma, and Operational Excellence programs.

Key Shared Accountabilities:-

· Build strong cross-functional collaboration and stakeholder engagement to deliver results.

· Ensure decisions are data-driven, risk-based, & aligned with business and compliance priorities.

· Equipment Reliability & Asset Management

· Production Delivery & Customer Supply

· Support technical team for new projects & stabilization of new installations.

Key Leadership behaviors:-

· Cross functional collaboration

· Quality & Compliance Mindset

· Lead the shift supervisor and team

· Easy to adaptability to change

· Continuous Improvement Mindset

· Takes ownership of plant performance

· Developing others and clear communication

KPIs:-

. No critical audit & repeat observation and Customer complaint.

· Recordable Injuries / LOPC : No

· Daily production plan adherence (%) & OEE Equipment utilization (%).

· Meeting Mopex/Opex numbers as per annual budget.

· Timely implementation of cost-saving projects.

· Right First Time (RFT) batches (%)

· Status of cleanliness, Plant Integrity & Housekeeping and GMP compliance.

Required Competencies:-

• API Manufacturing Expertise
• Leadership & Team Management
• Problem Solving & Analytical Skills
• cGMP & Regulatory Knowledge
• Data Analysis and Decision Making
• Coping with pressures & setbacks
• Manufacturing & Technical Knowledge
• Communication & Stakeholder Management

Minimum years of experience:-

12 to 20 years

Education:-

M.Sc. / Chemical Engineering