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..
ERP/SAP related all activity carried out (Like BOM, Routing, Stock of Raw material, Intermediates, Finished product every batch)
To prepare/revised and review all documents for peptide / API product related products documents as per process given by R&D with related to respective production block/plant.
Responsible for preparation/review all required documents for manufacturing department.
Responsible for implement the E-log and SAP in Manufacturing department.
Essential Functions:
- 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
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Additional Responsibilities:
