Senior Officer, Manufacturing Process Operations

Amneal Pharmaceuticals; Dahej; On-site; INR 800,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals in Gujarat/Dahej is seeking a seasoned professional for peptide API manufacturing. You will operate reactors and ancillary equipment, maintain BMR/BCR/BPR records, and ensure strict GMP adherence on a daily basis.

The role emphasizes process development, deviation resolution, safety training, and QA coordination with internal teams to drive quality and efficiency in manufacturing.

Qualifications

• Master's degree in chemistry or pharma is preferred.
• 5–7 years in peptide/API/medium-scale manufacturing operations.
• Experience with SOPs, GMP, and batch documentation.

Responsibilities

• Operate and monitor equipment used in API production and ensure readiness.
• Maintain BMR, BCR, BPR, and log deviations with QA coordination.
• Adhere to safety practices, PPE, and environmental guidelines.
• Assist in qualification/validation of equipment and processes.
• Support audits, cross-functional reviews, and continuous improvement.

Skills

Process development

GMP compliance

Batch record maintenance

Safety and PPE adherence

Quality control

Lean/process improvement

Training and mentoring

Documentation and QA coordination

Education

MSc Organic Chemistry

M.Pharm

Job description

Essential Functions

• Strong experience in solid-phase and liquid-phase peptide synthesis.
• Knowledge of hybrid technologies / Molecular Hiving preferred.
• Hands-on experience in process development of peptide pharmaceuticals.
• Exposure to scale-up processes will be an added advantage.
• Operate and monitor equipment used in various stages of API production such as reactors, centrifuges, dryers, millers, sifters, etc.
• Ensure cleanliness and readiness of equipment before batch charging through visual verification procedures.
• Maintain accurate records, including Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, and deviation reports.
• Execute batch operations strictly as per SOPs and GMP guidelines.
• Monitor and record process parameters in real-time to ensure adherence to specifications and quality.
• Report and coordinate with Engineering for any equipment breakdowns during the shift.
• Coordinate with QA for issuance and submission of documents and with the warehouse for material movement.
• Handle raw materials, intermediates, and APIs, ensuring proper storage, reconciliation, and documentation.
• Follow standard procedures for sampling and in-process testing of materials and intermediates.
• Maintain cleanliness and good housekeeping in the designated manufacturing area.
• Monitor utilities in the plant (e.g., steam, vacuum, chilled water) and report abnormalities.
• Monitor and record environmental conditions like temperature, humidity, and differential pressure in clean areas (Level-I, II, III).
• Perform daily verification and calibration checks of weighing balances.
• Participate in periodic equipment cleaning and preventive maintenance.
• Ensure proper handling and disposal of hazardous materials as per environmental guidelines.
• Identify process deviations, malfunctions, or quality concerns and report them immediately.
• Support continual improvement by suggesting ideas for optimization, efficiency, and waste reduction.
• Take mandatory safety and operational training via AIMS software and participate in hands-on skill-building sessions.
• Adhere strictly to safety practices and use PPE as per company safety protocols.
• Participate in emergency response activities such as managing spills or operational incidents.
• Ensure timely inventory of plant/process-related consumables.

Additional Responsibilities

• Support implementation of process improvement initiatives and lean manufacturing practices.
• Assist in the qualification and validation of equipment and processes as per regulatory and internal guidelines.
• Ensure readiness of the area for internal, external, and regulatory audits.
• Support investigation and documentation of deviations, change controls, and CAPAs in coordination with QA.
• Participate in cross-functional meetings to discuss production schedules, quality concerns, and improvement plans.
• Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability.
• Train and mentor junior staff/operators on standard procedures and safe working practices.
• Assist in preparation and review of SOPs related to manufacturing activities.
• Ensure adherence to environmental and safety norms in chemical handling and waste disposal.
• Actively participate in safety drills, risk assessments (HIRA), and incident investigations.
• Coordinate with stores for timely availability of raw materials, consumables, and packing materials.
• Report daily production updates to the shift in-charge or supervisor as required.

Qualifications

• Master's degree, M. Sc - Organic Chemistry - Preferred
• Master's degree, M. Pharmacy - Preferred

Experience

• 5 to 7 years in Peptide/ API/Intermediate manufacturing operations