Manager, Manufacturing API 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, Equipment Operation, GMP Compliance, SOP Adherence, Batch Manufacturing Record, Material Handling, In-Process Testing, Environmental Monitoring, Calibration, Hazardous Material Disposal, Deviation Reporting, Process Improvement, Safety Practices

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 Manager is responsible for executing and monitoring production processes in the API manufacturing plant, which involves operating specialized equipment, ensuring strict adherence to SOPs and GMP guidelines, and maintaining accurate batch records.