Executive, Manufacturing Process Operations

RXinsider LTD.; Dahej; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

RXinsider LTD. seeks a Senior Officer – Manufacturing Process Operations to execute API manufacturing processes, maintain quality and regulatory compliance, and operate critical equipment.

The role requires handling BMR/BCR/BPR documentation, performing in-process testing, and ensuring safe, compliant operations on the shop floor. Strong emphasis on GMP and audit readiness is essential.

Qualifications

• Master's degree preferred: MSc Organic Chemistry or MPharm.
• BE/BTech in Chemical Engineering.
• Experience 5–7 years in Peptide/API/Intermediate manufacturing operations.

Responsibilities

• Operate manufacturing equipment and ensure GMP compliance.
• Maintain batch records and deviation reports (BMR/BCR/BPR).
• Follow SOPs and GMP guidelines during batch operations.
• Coordinate with Engineering for equipment breakdowns.
• Handle materials, intermediates, and APIs with proper storage and documentation.
• Sample and test materials per procedures and maintain environmental controls.
• Maintain cleanliness and good housekeeping in the manufacturing area.
• Monitor plant utilities and report abnormal conditions.
• Record ambient conditions in clean areas and dispose of hazardous materials properly.
• Participate in safety drills, risk assessments, and incident investigations.
• Assist in equipment qualification/validation per regulatory guidelines.
• Prepare for internal/external/regulatory audits.

Skills

BMR preparation

API operations

Process monitoring

Inventory control

Education

MSc Organic Chemistry

MPharm

BE/BTech Chemical Engg

Job description

Job Description

Senior Officer – Manufacturing Process Operations is responsible for executing processes in the API manufacturing plant, ensuring product quality, regulatory compliance. This role includes operating key equipment, maintaining GMP documentation. The position requires a strong understanding of chemical process operations, safety standards, and documentation practices.

Essential Functions

• having knowledge on operation of manufacturing equipment
• Should Have Knowledge of hybrid technologies / Molecular Hiving preferred.
• Exposure to scale-up processes will be an added advantage.
• 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.
• Report and coordinate with Engineering for any equipment breakdowns during the shift.
• 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).
• Ensure proper handling and disposal of hazardous materials as per environmental guidelines.

Additional Responsibilities

• 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.
• Should investigate and documentation of deviations, change controls, and CAPAs in coordination with QA.
• Maintain discipline and GMP compliance on the shop floor and promote a culture of accountability.
• 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.

Qualifications

-Education:

• Master's degree, M. Sc - Organic Chemistry - Preferred
• Master's degree, M. Pharmacy- Preferred
• BE/ Btech Chemical engineering

Experience

• 05 to 07 years in Peptide/ API/Intermediate manufacturing operations

Skills

• Preparation of BMR and technical documents (IQ, OQ, PQ, etc.).
• API Manufacturing Operations - Intermediate to Advanced
• Process Monitoring and Troubleshooting - Intermediate
• Material Handling & Inventory Control - Basic to Intermediate