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Senior Officer, Manufacturing Process Operations

Amneal Pharmaceuticals
5-7 Years
Dahej, India
  • Posted 10 hours ago
  • Be among the first 10 applicants

Job Description

Essential Functions

 JOB DESCRIPTION

  • 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

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Pharmaceuticals
Employment Type:
Full time

Job ID: 152466247

Last Updated: 18-08-2026 10:43:46 PM
Homejobs in DahejSenior Officer, Manufacturing Process Operations

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Officer, Manufacturing Process Operations

Amneal Pharmaceuticals
Dahej, India

Skills:

Preparation of BMR and technical documents IQ OQ PQ etc., API Manufacturing Operations – Intermediate to Advanced, Material Handling Inventory Control – Basic to Intermediate, Process Monitoring and Troubleshooting – Intermediate, operation of manufacturing equipment, hybrid technologies Molecular Hiving

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