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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
Ensure Quality Products are being manufactured by processing operator in conformance with c-GMP/safety and hygiene requirements on shift-to-shift basis. Maintains overall disciplines and productivity.
Key Roles/Responsibilities:
- To take training before executing any Filling operation.
- To undergo the various training planned by department or company then learn & implement the same at the workplace.
- To be committed when fill the document (ALCOA++) Attributable, Legible (Readable), Contemporaneous (online), Original, Accurate and complete, consistent, enduring, available and traceable.
- Follow the gowning procedure and personal hygiene as per SOP.
- To be committed for GMP, GDP and DI practices to avoid overwriting and errors, etc. in documents.
- Use self-login ID and password & do not share it to anyone.
- Follow instruction for new machine/methodology in accordance with the quality standards.
- Do status labelling & affix the status label.
- Check and ensure that temperature, RH and differential pressure of cubicle shall be within limit.
- Visually check for the absence of any residue of previous product or any extraneous matter.
- Use appropriate personal protective equipment’s like face shield, Goggle, Hand gloves & nose mask during machine operation, machine cleaning and follow safety regulation.
- Know hazards associated with given product/ machine/equipment/ tools and adopt necessary protection against identified hazards.
- Identify the Hazards & report any near miss, unsafe act, unsafe condition to your supervisor immediately.
- Do the calibration of balance.
- Proper arrangement in blending room, MCDP area, PM issued room and WIP.
- Do resin blending and Transfer of movable equipment as on when required.
- To maintain good hygiene, safety practices and cGMP Practices.
- In case of any non-conformity or deviation inform supervisor immediately.
- Daily consumables item stock maintenance in area.
- Write off material transfer to silt area.
- Refill Sterilium & 70% IPA bottles under supervision.
- 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.
- Train new employees on operation of equipment and related activity.
- Any other activity from time to time which his supervisor / company feels appropriate.
