Softgel Production Operator

Responsibilities :

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Strict adherence to safety, health and environment.

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Carry out Manufacturing activities by following and monitoring standard operating procedure (SOP) and current Good Manufacturing Practice (cGMP).

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To ensure effective implementation of RFT and Data integrity policy.

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Maintenance, upkeep of the department, premises and equipment.

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To maintain discipline in the section

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To protect product and material against spillage and deterioration

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Monitoring and Safely operating the machine as per SOP, with minimum rejection & maximum output.

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Improvement, continuous review and up gradation of existing SOPs & work systems and to ensure their strict implementation.

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To track execution of cleaning activity of non-product contact/indirect product contact surfaces

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Discussion of the day-to-day work with Section Head.

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To Co-ordination with other sections and departments.

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Check and Monitor for cleanliness and environmental conditions of area w.r.t. temperature, relative humidity, differential pressure, microbial control, fly control and AHU handling (SCADA).

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To ensure that all materials and finished products are stored under the appropriate conditions as per specification and along with batch segregation and stock rotation.

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To perform study as per various Study Protocol in areas.

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To perform activities such as Cleaning, Line Clearance, Operation, PPM and Calibration of equipment and area as per roles and responsibilities.

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To cooperate for investigation of deviations, OOS, OOT and complaints observed as per Standard Procedure.

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To perform timely entries of data and completeness of Batch Manufacturing Record, Checklist, Logs and Protocols on Issued Documents.

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To perform activities such as Calibration, Sanitization, Maintenance of DM Store, Inprocess store and Clean equipment Area.

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Maintain and monitor inventory required in Department and Scrap the damaged inventory.

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To transfer Inprocess and Finished goods to Inprocess store.

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Checking raw material is dispensed for manufacturing of batches and Issuance of batches for processing of next stage and also ensure Preparatory set up work prior to start of manufacturing activity.

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To monitor and maintain correct Status labelling of containers, equipments, area and materials.

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Identification, classification, finding, quarantine and destruction of rejects generated during manufacturing process.

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Calibration of equipment, instruments and weighing balances and PPM as per schedule and maintaining records of the same.

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To Operate SAP system, PRAMAAN (E-Log), LMS and Cipdox system based on roles and rights Provided in the application.

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To involve in the training conducted in the section (Scheduled training, Training on changes, Miscellaneous) and also as per the nominations given by Section Head/ Department Head.

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Participating in Process Validation and Cleaning Validation in co-ordination with Quality Assurance.

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To prepared qualification & requalification of machine / equipment / area and to perform FMECA of machines in manufacturing department.

Preferred candidate profile

Diploma in pharmacy/mechanical/electrical along with minimum one year experience in softgel manufacturing.

Recruiter

Mohaneswara Reddy

https://www.linkedin.com/in/mohaneswarareddy