Manager API Manufacturing

Location: Barnāla

1. Purpose of the Role

To plan, direct, and control API production operations to achieve targeted output, quality, cost efficiency, and regulatory compliance while ensuring safe, GMP-compliant, and environmentally responsible manufacturing.

2.

Key Responsibilities

A. Production Planning & Operations

- Plan, execute, and monitor day-to-day API manufacturing activities as per approved production schedules.
- Ensure optimum utilization of men, machinery, materials, and utilities.
- Achieve production targets with minimal downtime and wastage.
- Coordinate with Planning, QC, QA, Engineering, and Stores for uninterrupted production flow.

B. GMP & Regulatory Compliance

- Ensure compliance with cGMP, WHO-GMP, USFDA, EU-GMP, and other regulatory standards.
- Implement and maintain SOPs, BMRs, logbooks, and manufacturing documentation.
- Ensure adherence to validated processes and approved change control procedures.
- Support regulatory audits and inspections; ensure timely closure of observations.

C. Quality & Process Control

- Ensure production is carried out as per approved batch manufacturing records.
- Monitor critical process parameters and ensure product quality consistency.
- Investigate deviations, OOS/OOT, and implement CAPA in coordination with QA.
- Drive continuous improvement initiatives to enhance yield and reduce reprocessing.

D. Safety, Health & Environment (EHS)

- Enforce safe operating practices and compliance with EHS norms.
- Ensure proper handling, storage, and disposal of hazardous chemicals and waste.
- Promote safety culture, conduct toolbox talks, and ensure incident reporting and investigation.

E. Team Management & Development

- Lead, mentor, and supervise production officers, supervisors, and operators.
- Conduct training on SOPs, GMP, safety, and process improvements.
- Monitor manpower deployment, shift planning, and performance evaluation.
- Foster discipline, teamwork, and accountability on the shop floor.

F. Cost Control & Efficiency

- Monitor and control production costs, consumables, and energy usage.
- Improve batch cycle times, yields, and overall equipment effectiveness (OEE).
- Support budgeting and cost-reduction initiatives.

G. Coordination & Reporting

- Prepare and review daily, monthly production reports and MIS.
- Coordinate with Supply Chain, QA, Engineering, and Maintenance for smooth operations.
- Escalate critical issues impacting safety, quality, or production timelines.

3. Educational Qualification

- B.Tech / B.E. in Chemical Engineering (Mandatory)

4. Experience Requirements

- 10–15 years of experience in API manufacturing, with at least 4–5 years in a managerial/supervisory role.
- Hands-on experience in large-scale API production operations.

5. Technical & Functional Skills

- Strong knowledge of API manufacturing processes and unit operations.
- In-depth understanding of GMP, regulatory guidelines, and audit requirements.
- Process optimization, troubleshooting, and yield improvement skills.
- Working knowledge of SAP/ERP systems and MS Office.

6. Behavioral Competencies

- Strong leadership and decision-making ability.
- Excellent communication and cross-functional coordination skills.
- High integrity, discipline, and compliance mindset.
- Ability to work under pressure in a regulated manufacturing environment.

7. Compliance & Accountability

- Responsible for adherence to company policies, statutory requirements, and regulatory standards.
- Accountable for production output, quality, safety, and manpower management within the assigned API block.