Description

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..

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 and monitor general manufacturing equipment including autoclaves, ovens, stills, and filtration apparatus in the pharmaceutical manufacturing area.
Handle raw materials, intermediate products, and finished pharmaceutical goods in accordance with established SOPs and safety guidelines.
Mix and blend compound ingredients for liquid products, suspensions, ointments, and other pharmaceutical dosage forms.
Perform general maintenance tasks on pumps, homogenizers, filter presses, and tablet compression machines as required.
Execute standard operating procedures in full compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements.
Maintain accurate and complete batch documentation records as per GMP and internal quality standards.
Ensure all manufacturing activities comply with applicable regulatory requirements including FDA and EMA guidelines.
Participate in process improvement projects and functional team initiatives to enhance quality, reduce costs, and optimize production scheduling.
Support area cleaning and sanitization activities to maintain manufacturing area standards.

Additional Responsibilities

QUALIFICATIONS

Education

B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred

Experience:

5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

Executive, Manufacturing Process Operations