Senior Executive, Intermediate Cleanroom

Amneal Pharmaceuticals LLC; Dahej; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Amneal Pharmaceuticals LLC is seeking a Senior Executive for Intermediate Cleanroom operations. You will operate and monitor API production equipment, maintain BMR/BCR/BPR records, and coordinate with engineering for shift breakdowns.

Maintain CGMP-compliant documentation and ensure safety and housekeeping in cleanroom areas. You will handle materials, perform sampling/testing, and monitor process parameters online, ensuring quality and timely batch completion while collaborating with QA and

Qualifications

• Minimum 8 years of experience in current role.
• Qualification: B.E Chemical / B.Tech Chemical / M.Sc Organic Chemistry.
• Experience with API/Intermediates manufacturing and CGMP.

Responsibilities

• Operate and monitor manufacturing equipment (reactors, centrifuge, dryer, mill, sifter).
• Maintain batch records (BMR, BCR, BPR) and logs.
• Coordinate with engineering for shift breakdowns and utilities monitoring.
• Ensure cleanliness and good housekeeping in cleanroom areas.
• Handle raw materials, intermediates, and finished products with proper records.
• Record, sample, and test intermediates and materials for quality."
• Monitor process online and maintain process parameters per specs.
• Adhere to SOPs, CGMP, and safety procedures; participate in training and emergencies.
• Coordinate with QA for document issuance and warehouse for RM/API.
• Maintain inventory for consumables and review manufacturing documents.

Skills

CGMP awareness

Documentation skills

Shift coordination

Equipment operation

Safety procedures

Education

B.E/B.Tech Chemical

M.Sc Organic Chemistry

Tools

AIMS software

Job description

Senior Executive, Intermediate Cleanroom

Job Description

Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as reactors, Centrifuge, Dryer, Miller, sifter etc.
Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment’s usage logs and Deviation reports if, any.
To co-ordinate with engineering department for the shift break down jobs.
To monitor the utility operation in the plant and report any abnormality to engineering department.
Collaborate with other shop floor personnel, shift in-charges, and cross-functional teams to ensure efficient and coordinated production.
Before charging of batch, cleanliness of Equipment’s to be verified by visual verification procedure.
To maintain good housekeeping in respective manufacturing area during process.
Receive, store, and handle raw materials, intermediates, and finished products. Maintain accurate reconciliation records and follow proper material handling procedures.
Follow established procedures to maintain product quality and consistency. This may involve sampling and testing intermediates, raw materials, and finished products.
To monitor the process online and record/fill the entire document legible.
Continuously monitor & maintain process parameters as per the desired product specifications and quality.
To record and maintain all the documents online as per CGMP.
Execute batch processing tasks according to standard operating procedures (SOPs), Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR), and maintain the details of records in equipment usage logs Ensure that all steps are carried out accurately and in a timely manner.
To monitor and record temperature, Humidity and differential pressure in clean area (Level-I, Level-II & III).
To check and record daily weighing balance calibration and verification.
To take training online in AIMS software.
Participate in training programs to enhance knowledge and skills related to API/Intermediate’s manufacturing and safety point of view.
Adhere to and promote safety practices, including the use of personal protective equipment (PPE) and following safety procedures to prevent accidents or incidents.
Be prepared to respond to emergencies, such as spills, leaks, or safety incidents, by following established emergency procedures.
Participate in equipment cleaning and maintenance activities to ensure equipment is in good working condition.
Identify and address issues or deviations in the manufacturing process, such as equipment malfunctions or variations in product quality.
Comply with environmental regulations, including proper waste disposal and following procedures for managing hazardous materials.
Identify opportunities for process optimization, efficiency improvements, and waste reduction and communicate suggestions to higher-level personnel.
To co-ordinate with QA department for documents issuance/submission and warehouse for RM, Intermediate, API issuance/submission as per requirement.
To be maintained plant/process related consumable items Inventory as per requirement.
To review the manufacturing department executed documents like, Batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch packing Record (BPR) etc..

Qualifications

Minimum 8 years of Experience in current job role. Qualification: B. E Chemical / B. Tech Chemical / M. Sc Organic Chemistry

Job Info

• Job Identification 7371
• Job Category Manufacturing Process Operations