Designation: Jr. Officer / Officer / Sr. Officer Peptide Manufacturing

Department: Manufacturing Peptide / API

Jr. Officer / Officer – Manufacturing Process Operations | API Manufacturing | Peptide Production

Job Summary The Jr. Officer / Officer/Sr. Officer – Manufacturing Process Operations is responsible for executing day-to-day production activities in the peptide/API manufacturing plant. The role involves operating equipment, maintaining GMP documentation, monitoring process parameters, and ensuring adherence to safety and quality standards. The position works under the guidance of senior team members and supports smooth plant operations.

Essential Functions

- Perform manufacturing activities for peptide/API production as per SOPs and BMR instructions.
- Operate equipment such as reactors, centrifuges, dryers, filters, and peptide synthesizers (manual/automated) under supervision.
- Assist in peptide synthesis operations.
- Ensure equipment cleanliness and readiness before batch execution.
- Record process parameters and update BMR/BCR/BPR documents accurately.
- Follow GMP, safety, and data integrity practices during all operations.
- Handle raw materials, intermediates, and finished products as per defined procedures.
- Coordinate with QA for line clearance, documentation, and sampling activities.
- Support in-process checks and sampling as per SOP.
- Report any deviations, abnormalities, or equipment issues to the supervisor.
- Maintain housekeeping and cleanliness in the manufacturing area.
- Monitor basic utilities such as temperature, pressure, vacuum, etc., during operations.
- Follow PPE and safety guidelines strictly while handling chemicals and solvents.
- Assist in equipment cleaning and preventive maintenance activities.




- Participate in shift-wise production activities and ensure timely completion of batches.
- Maintain logbooks and equipment usage records.

Additional Responsibilities

- Support senior team members in process execution and troubleshooting.
- Assist in preparation and revision of SOPs and manufacturing documents.
- Participate in audits (internal/external) by ensuring area readiness.
- Support deviation reporting, change control, and CAPA documentation.
- Contribute to continuous improvement initiatives (5S, lean practices).
- Attend training programs (GMP, safety, technical).
- Ensure compliance with environmental, health, and safety (EHS) guidelines.
- Coordinate with stores for material issuance and return.

Qualifications

Education:

- M.Sc. (Organic Chemistry) / B.Sc. (Chemistry)
- B.E. Chemical / B.Tech Chemical engineering

Experience:

- Jr. Officer: 1 to 2 years
- Officer: 2 to 4 years
- Sr. Officer: 4 to 5 years (Preferably in Peptide / API / Intermediate Manufacturing)

Skills Required

- Basic knowledge of peptide synthesis
- Understanding of GMP and documentation practices
- Knowledge of batch manufacturing records (BMR/BCR/BPR)

- Basic understanding of equipment operations (reactors, centrifuges, dryers)
- Awareness of safety practices and PPE usage
- Basic troubleshooting and observation skills

- Positive communication and teamwork
- Willingness to work in shifts

Key Competencies

- Execution Excellence: Ability to follow instructions and SOPs accurately

- Compliance Orientation: Adherence to GMP and safety norms
- Learning Attitude: Eagerness to learn peptide manufacturing processes
- Teamwork: Coordination with cross-functional teams

- Attention to Detail: Accurate documentation and monitoring

📌 Officer / Sr.Officer - Peptide Mfg. at Raks Pharma Pvt Ltd Dahej
🏢 Amneal Pharmaceuticals
📍 Dahej