Senior Executive-Production

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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

Senior Executive-Production

Job Description

Supervises quality products are being manufactured in conformance with c-GMP/safety and hygiene requirements on shift to shift basis. Maintains overall discipline and productivity.

• Allocates workmen for different workstations on shift to shift basis.
• Ensure no stoppage of operation / machines due to non-availability of manpower and any kind of machine breakdown.
• Supervises the line operations and related activities and participates in Validation /Trial / qualification activities as per the protocol.
• Checks and cross-verify line clearance during Batch/Product changeover.
• Maintains c-GMP practices along with documentation in various records.
• To maintain good hygiene, safety practices and disciplines.
• Fills in-process parameters/Reconciliation in packaging documentation.
• Review/check BPR and other documents before submission to next stage.
• Involve in investigation of event/ market complaints and implementation of CAPA.
• Handles minor setting issues, Serialization and aggregation in machines.
• Monitors the speed of the machine and output according to the run time.
• Imparts on job/ Classroom training to the workmen/Technical staff and other employee for SOP and cGMP systems.
• Monitors and reports the unauthorized movement of workmen from the line.
• Preparation of new SOPs and updating of existing SOPs.
• Reports on day-to-day basis activities in SAP system (If SAP user id is available).
• Verifies the balances on daily and monthly basis.
• Maintenances and calibration of various instruments and equipment.
• Initiate Change controls and deviations, CAPA, Change controls in electronic system as per the need (If authorization is available).
• Check all the calibration tags of equipment, instruments, and fire extinguishers for their due date time to time.
• Knowledge and involvement in SFTI, OE & 6S Activities.
• Knowledge and involvement in ISO 14000 & 13485 and EHS compliance (Near Miss reporting/Learning Incident, UA & UC).
• Prepare and cross-verify the material return note (MRN) after the completion batch/product campaign.
• Prepare the line rejection note (LRN), material requisition note (MRQN) wherever required.
• Take-up the responsibilities of the immediate supervisor for the section in his absence
  
  

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