Job Description

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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

For Ophthalmic production Aseptic filling supervisor.

• To take training before executing any manufacturing operation and use Ensur for training (If user Id available).
• To be committed when filling the document contemporaneous (online), Legible, Readable, Accurate and Original.
• To be committed for GDP practices to avoid overwriting and errors, etc. in documents.
• Use self-login ID and password & do not share it to anyone.
• Allocates workmen for different workstations on shift-to-shift basis.
• Follow instruction for new machine/methodology in accordance with the quality standards.
• Do status label as per SOP.
• 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 products/ machine/equipment/ tools and adopt necessary protection against identified hazards.
• Identified the Hazards & report any near miss, unsafe act, unsafe condition to your supervisor immediately.
• To maintain good hygiene, safety practices and cGMP Practices.
• To set the parameter of machine as per defined in the BMR/SOP.
• Check the Raw material / SFG product name, batch number, weight of material as per BMR, if any mismatch inform to supervisor.
• Monitors and reports the unauthorized movement of workmen from line.
• To run and supervise the machine as instructed by line/ shift superiors.
• Checking of line clearance during batch change over.
• Verifies the balances on daily and monthly basis.
• Participate in machine qualification activities.
• Checks all the calibration tags of equipment, instruments and fire extinguisher for their due date time to time.
• In-process testing as defined in Batch Manufacturing Record.
• Preparation of Material Return Note (MRN), Material Requisition Note (MRQN),
• undefined
• Handle the rejection as per defined in the SOP.
• In case of any non-conformity or deviation inform the line supervisor immediately.
• 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.
• Knowledge and involvement in Daily Management System.
• Knowledge and involvement in ISO 14000 & 13485.
• Check and review the BMR before start of next operation.
• Any other activity from time to time which his supervisor / company feels appropriate.