Technical Staff

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Technical Staff

Job Description

To take training before execute any packing activity. To be committed when fill the document (ALCOA+) Attributable, Legible (Readable), Contemporaneous (online), Original, Accurate and complete, consistent, enduring and available. To be committed for GDP practices to avoid overwriting and errors etc.in documents. Use self-login ID and password only & do not share it to anyone. Follow instructions for new machine/methodology in accordance with the quality standards. Clean the equipment and area for Type A, B & D type in case of product / batch change and major mechanical related maintenance job. Visually check for the absence of any residue of previous product or any extraneous matter. Do status label as per SOP. Use appropriate personal protecting equipment as per the requirement (Refer COSHH card and PPE matrix) during machine operation, machine cleaning, packing operation and follow safely regulation. Identify the hazards and report any unsafe act/condition, near miss/ learning incident to supervisor immediately. To maintain good hygiene, safety practices and disciplines. Takes the changeover on the machine from product to product or batch to batch as per SOP. To set the machine as defined in the BPR/SOP. To set the machine with Supervisory password to edit the parameter and get it checked with supervisor before starting the operation. Check the tablet/capsule and packaging material for correctness of product, batch number and artwork no. as per BPR if find any mismatch inform to supervisor. Follow FIFO for usage of PM. To transfer the SFG and packing material from WIP/ PM storage area to Packing line and Finished goods to FG store. To submit the correct specimen before forwarding for approval at the start of batch/shift. Do the challenge test as per the SOP and BPR. To check the quantity and quantity of tablets/capsules, Blisters, leaflet in showboxes, canister in a bottle, quality of printing, sealing, labelling, outsert missing, quantity of shipper and for any other visual defects periodically. To run the machine and involve in packing activity as instructed by line/shift supervisor. Perform packaging activity as instructed by line/shift supervisor. In case of any event, non-conformity or deviation, inform the line supervisor immediately. Handle the rejections as per defined in the SOP. Keep the machine clean throughout the shift along with surrounding area. Ensure there is no spillage of material on the floor. Delivers the expected output from that machine in the shift. Address the minor mechanical issues in terms of machine setting from time to time and inform supervisor during any breakdown where maintenance helps are required. Know hazards associated with given product/machine/equipment/tool & adopt necessary protection against identified hazards. Train the new employee on operation of equipment and related activity. Any other activity from time to time which his supervisor/company feels appropriate.

• To take training before execute any packing activity.
• To be committed when fill the document (ALCOA+) Attributable, Legible (Readable), Contemporaneous (online), Original, Accurate and complete, consistent, enduring and available.
• To be committed for GDP practices to avoid overwriting and errors etc.in documents.
• Use self-login ID and password only & do not share it to anyone.
• Follow instructions for new machine/methodology in accordance with the quality standards.
• Clean the equipment and area for Type A, B & D type in case of product / batch change and major mechanical related maintenance job.
• Visually check for the absence of any residue of previous product or any extraneous matter.
• Do status label as per SOP.
• Use appropriate personal protecting equipment as per the requirement (Refer COSHH card and PPE matrix) during machine operation, machine cleaning, packing operation and follow safely regulation.
• Identify the hazards and report any unsafe act/condition, near miss/ learning incident to supervisor immediately.
• To maintain good hygiene, safety practices and disciplines.
• Takes the changeover on the machine from product to product or batch to batch as per SOP.
• To set the machine as defined in the BPR/SOP.
• To set the machine with Supervisory password to edit the parameter and get it checked with supervisor before starting the operation.
• Check the tablet/capsule and packaging material for correctness of product, batch number and artwork no. as per BPR if find any mismatch inform to supervisor. Follow FIFO for usage of PM.
• To transfer the SFG and packing material from WIP/ PM storage area to Packing line and Finished goods to FG store.
• To submit the correct specimen before forwarding for approval at the start of batch/shift.
• Do the challenge test as per the SOP and BPR.
• To check the quantity and quantity of tablets/capsules, Blisters, leaflet in showboxes, canister in a bottle, quality of printing, sealing, labelling, outsert missing, quantity of shipper and for any other visual defects periodically.
• To run the machine and involve in packing activity as instructed by line/shift supervisor.
• Perform packaging activity as instructed by line/shift supervisor.
• In case of any event, non-conformity or deviation, inform the line supervisor immediately.
• Handle the rejections as per defined in the SOP.
• Keep the machine clean throughout the shift along with surrounding area.
• Ensure there is no spillage of material on the floor.
• Delivers the expected output from that machine in the shift.
• Address the minor mechanical issues in terms of machine setting from time to time and inform supervisor during any breakdown where maintenance helps are required.
• Know hazards associated with given product/machine/equipment/tool & adopt necessary protection against identified hazards.
• Train the new employee on operation of equipment and related activity.
• Any other activity from time to time which his supervisor/company feels appropriate.