Assistant Manager - Production API

Responsibilities

1. Production Planning & Shop Floor Execution

• Batch Scheduling: Execute daily and weekly production schedules based on master planning to meet production and market delivery targets.
• Unit Operations: Oversee critical API manufacturing operations, including reaction kinetics, distillation, centrifugation, filtration, drying, micronization, and final cleanroom packing.
• Resource Optimization: Effectively allocate manpower across shifts, minimize equipment downtime, and optimize raw material and solvent consumption.

2. Regulatory Compliance & USFDA Audit Readiness

• cGMP & ALCOA+ Compliance: Ensure strict adherence to current Good Manufacturing Practices (cGMP), ICH guidelines, and Data Integrity principles.
• Audit Representation: Act as a key technical representative during internal, customer, and regulatory audits, including USFDA, MHRA, and EU-GMP inspections.
• Cleanroom Controls: Ensure final API isolation activities comply with applicable cleanroom classification standards and cross-contamination control requirements.

3. Quality Management Systems (QMS)

• Documentation Review: Author, review, and ensure timely closure of Batch Manufacturing Records (BMRs), Batch Production Records (BPRs), and Standard Operating Procedures (SOPs).
• Deviations & Investigations: Lead Root Cause Analysis (RCA) for process deviations, Out-of-Specification (OOS) results, and production incidents.
• CAPA & Change Control: Develop and implement effective Corrective and Preventive Actions (CAPA) and manage formal Change Controls for process modifications.

4. Technology Transfer & Process Validation

• Scale-Up: Coordinate with the Process Development/R&D and Technology Transfer teams for the seamless introduction and scale-up of new products.
• Validation Protocols: Execute process validation, equipment qualification (IQ/OQ/PQ), and cleaning validation activities to ensure regulatory compliance.

5. EHS (Environment, Health & Safety)

• Ensure safe handling of chemicals, hazardous/exothermic reactions, and solvent recovery operations in accordance with applicable industrial safety standards.

• Promote a zero-accident culture by ensuring proper PPE usage and strict implementation of Lockout/Tagout (LOTO) procedures during maintenance activities.

• 6. Preferred Profile

  10 to 15 years of relevant experience in API manufacturing
  Experience in a USFDA-Approved manufacturing facility preferred