Amneal Pharma is hiring for the role of Officer, Manufacturing Process Operations in the Manufacturing department at Dahej SIR, Gujarat, India; Dahej, Bharuch, Gujarat, IN. This role is focused on API and injectable manufacturing operations, production documentation, equipment monitoring, GMP compliance, material handling, and coordination with quality, engineering, warehouse, and other shop floor teams.
| Company | Amneal Pharma |
| Position | Officer, Manufacturing Process Operations |
| Department | Manufacturing |
| Location | Dahej SIR, Gujarat, India; Dahej, Bharuch, Gujarat, IN |
| Experience | 2-5 Years |
The selected candidate will operate and monitor manufacturing equipment and instruments used in various stages of API production, including reactors, centrifuge, dryer, miller, sifter and related process equipment. The role also involves maintaining accurate production records such as Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR), equipment usage logs, deviation reports, and other manufacturing documents as per cGMP requirements.
Key Responsibilities
- Operate manufacturing equipment such as autoclaves, sterilizers, filtration units, mixing vessels, washing machines, and filling support systems as per SOPs.
- Execute injectable manufacturing activities including solution preparation, filtration, sterilization, filling support, and component handling as per batch records.
- Handle raw materials, containers, closures, intermediates, and finished injectable products in compliance with aseptic and GMP standards.
- Maintain accurate batch manufacturing records, equipment logbooks, and production documentation in line with GDP requirements.
- Perform equipment cleaning, sanitization, line clearance, and basic maintenance as per approved procedures.
- Ensure compliance with cGMP, aseptic practices, safety guidelines, and regulatory requirements including FDA and EMA standards.
- Support environmental control practices and maintain cleanliness of general and classified manufacturing areas.
- Identify and report deviations, equipment malfunctions, or process abnormalities to supervisors promptly.
- Participate in in-process checks and sampling activities to support product quality and batch release requirements.
- Contribute to process improvement initiatives focused on productivity, quality enhancement, cost control, and schedule adherence.
- Coordinate with the engineering department for shift breakdown jobs and report abnormalities in utility operations.
- Collaborate with shop floor personnel, shift in-charges, and cross-functional teams for efficient production execution.
- Verify equipment cleanliness by visual verification procedure before batch charging.
- Maintain good housekeeping in the respective manufacturing area during process activities.
- Receive, store, and handle raw materials, intermediates, and finished products while maintaining accurate reconciliation records.
- Monitor process parameters online and record required data legibly as per product specifications and quality requirements.
- Monitor and record temperature, humidity and differential pressure in clean area Level-I, Level-II and III.
- Check and record daily weighing balance calibration and verification.
- Participate in training programs related to API/Intermediate manufacturing, AIMS software, and safety practices.
- Follow safety practices, use PPE, and respond to emergencies such as spills, leaks, or safety incidents as per established procedures.
- Coordinate with QA for document issuance/submission and with warehouse for RM, Intermediate, API issuance/submission as per requirement.
- Maintain plant/process related consumable items inventory as per requirement.
- Review manufacturing department executed documents such as BMR, BCR, BPR and related records.
- Carry out ERP/SAP related activities including BOM, routing, stock of raw material, intermediates, and finished product for every batch.
- Prepare, revise and review documents related to peptide/API products as per process given by R&D for the respective production block/plant.
- Support implementation of E-log and SAP in the Manufacturing department.
Qualification
- Education: Bachelors Degree (BA/BS) B.E. – Required
- M. Pharm M. Pharm – Preferred
Experience
- Experience: 2 years or more in 2 – 5 Years
How to Apply
Interested candidates can apply online through the official application link provided below.