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

ExecutiveEssential Skills : Well worse with tableting and capsule manufacturing techniques including Granulation, Compression, coating and other Processing Operations
Desirable Skills: Planning, Scheduling, Communication, Computers, Troubleshooting, Leadership.

Key Roles/Responsibilities:

· Allocates workmen for different workstations on shift-to-shift basis.

· Ensure no stoppage of operation / machines due to non-availability of man power and any kind of machine breakdown.

· Supervises the line operations and participate in Validation activities as per the protocol.

· Maintains c-GMP practices along with documentations in various records.

· Fills in process parameters & manufacturing documentations.

· Involvement in the manufacturing and documentation of Pilot batches in the existing Pilot plant in conformance with cGMP.

· Involvement in the manufacturing and documentation of trial/pre exhibit/ exhibit /commercial batches.

· Fills and checks BMR before submission to the superiors.

· Handles minor parametric setting issues in various machines and products.

· Monitors speed of machine and output according to the run time.

· Imparts on job/ Classroom training to the concern workmen and supervisor for SOP and cGMP systems.

· Imparts induction activity to all new joining.

· Checks the compressed tablets/coated tablets/filled capsules randomly. If any discrepancy is observed, reports to superiors.

· Monitors and reports the unauthorized movement of workmen from line.

· Takes up the responsibilities of the immediate supervisor for the section in his absence.

· 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.

· Knowledge and involvement in SFTI & 5S Activities.

· Knowledge and involvement in ISO 14000 & 13485.

· Any other activity from time to time which his supervisor / company feel appropriate.

· Checking of line clearance during batch change over.

· In process testing as defined in Batch Manufacturing Record.

· Perform summary after completion of sub-process like compression and coating.

Review quality document.