Assistant, Lyophilizer at Amneal India

, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

22 Jun, 26

Salary

0.0

Posted On

24 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Lyophilizer Operation, Equipment Monitoring, Documentation, Batch Manufacturing Record, Batch Cleaning Record, Batch Packing Record, Material Handling, Process Monitoring, CGMP Compliance, SOP Adherence, Calibration, Troubleshooting, Safety Practices, Waste Disposal, Process Optimization, Inventory Management

Industry

Pharmaceutical Manufacturing

Description

Operate and monitor manufacturing equipment and Instrument used in various stages of API production, such as LYOPHILIZER, Glass Assembly, Buckner filter, addition pot Centrifuge, Dryer, Miller, 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 for LYOPHILIZER 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 LYOPHILIZER and other 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 LYOPHILIZER 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. To check and record daily weighing balance calibration and verification. To take training online in AIMS software. Participate in training programs to enhance LYOPHILIZER 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 LYOPHILIZER and other 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 LYOPHILIZER 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 LYOPHILIZER 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 LYOPHILIZER and plant/process related parts and consumable items Inventory as per requirement. To handle and monitoring and troubleshooting of LYOPHILIZER area activities during execution of process operation.

Responsibilities

The role involves operating and monitoring manufacturing equipment, particularly the Lyophilizer, used in API production while maintaining accurate production and quality documentation like BMRs and deviation reports. Responsibilities also include coordinating with engineering for breakdowns, monitoring utilities, ensuring equipment cleanliness, handling materials, and adhering strictly to SOPs and CGMP guidelines.