Assistant Manager, Manufacturing Process Operations at Amneal India

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

20 Jun, 26

Salary

0.0

Posted On

22 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Peptide Synthesis, Process Development, Scale-Up Processes, API Production, GMP Guidelines, SOPs, Equipment Operation, Batch Manufacturing Record, Quality Assurance Coordination, Material Handling, In-Process Testing, Environmental Monitoring, Equipment Calibration, Safety Practices, Deviation Reporting, Process Improvement

Industry

Pharmaceutical Manufacturing

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. • Review completed manufacturing records for accuracy, completeness, and compliance with SOPs. 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. • Support periodic review of equipment performance and suggest improvements for efficiency. • 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.

Responsibilities

The Assistant Manager is responsible for executing and monitoring API manufacturing production processes, ensuring adherence to SOPs, GMP guidelines, and real-time parameter monitoring. This includes operating and maintaining critical production equipment, managing documentation like BMRs, and coordinating material movement and quality checks.