Operator - Oral Solid Dose (OSD) Manufacturing

Role & 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 in an orderly fashion to permit 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 Isuued Documents.

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To perform activities such as Calibration, Sanitization, Maintanance of Processing and Non-Processing 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 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 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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Reconciliation of Quantities at various stages of manufacturing.

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To check received work order and Dispensed batch from Store.

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Online stage wise review, compilation of batch manufacturing record and submission to department head.

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Installation, operation and performance qualification of new machines and requalification of existing machines as per defined frequency and to perform FMECA of machines in manufacturing department.

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Supervision and duty allocation to Staff & workmen in the section.

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Execute the dispensing of raw material activity as per manufacturing plan

Preferred candidate profile

Candidate with full time Diploma / B.Sc degree & minimum 1 year of experience in OSD Formulation Production

Recruiter

Mohaneswara Reddy

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