Executive - Production

Piramal Critical Care, Inc.; India; On-site; INR 400,000 - 600,000; Full time

Job summary

Piramal Pharma Solutions seeks an Executive - Production to supervise granulation operations and ensure quality compliance. The role involves shift-wise manpower allocation, line supervision, and adherence to c-GMP and safety standards.

You will review BMRs, maintain ALCOA+ documentation, and support validations, calibrations, and process improvements across the production line. On-site role with exposure to GMP environments in a fast-paced CDMO setting.

Responsibilities

• Allocates workmen for different workstations on a shift-to-shift basis.
• Supervise/Line operations like weight verification, product recipe selection, machine setting, spray rate checking, In-process check as per frequency during coating operation.
• Review the batch manufacturing record and other quality documents.
• Fills in process parameters, Batch manufacturing record (BMR) and GMP documents/records following ALCOA+ principles.
• Ensure no stoppage of operation/machines due to manpower unavailability or machine breakdown.
• Participates in validation activities like Equipment/Area and Trial/Study/Pre-exhibit/Exhibit/validation batch activities per protocol.
• Maintains c-GMP practices with documentation in various records.
• Handles minor parametric setting issues in various machines and products.
• Monitors machine speed and output according to runtime.
• Reports unauthorized movement of workmen from line.
• Takes up responsibilities of the immediate supervisor in his absence.
• Helps section in charge for preparing SOP and other GMP documents.
• Reports day-to-day activities in SAP system (if SAP user ID is available).
• Calibration checks of balances/Timer/Timer Synchronization as required.
• Participate in machine qualification activities per Qualification protocol when required.
• Check calibration/qualification tags of equipment, instruments, or fire extinguishers for due dates.
• Check line clearance during product/changeover and monitor Temperature, RH/Pressure Gradient, area cleaning and disinfections.
• Involvement in EHS, SFTI, 6S, ISO 14001 & 13485 activities.
• Fill safety checklist and provide toolbox talks, report Unsafe conditions/acts and Learning incidents (Near miss).
• Perform hazard identification and risk assessment (HIRA) per SEP and provide training to subordinates.
• Any other activity as directed by supervisor/company.

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

Executive - Production

Job Description

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

• Allocates workmen for different workstations on a shift-to-shift basis.
• Supervise/Line operations like weight verification, Product recipe selection , machine setting, spray rate checking,In-process check as per frequency etc.at start/during coating operation.
• Review the batch manufacturing record and other quality documents.
• Fills in process parameters, Batch manufacturing record (BMR) and GMP documents/record where required by following ALCOA+ principles.
• Ensure no stoppage of operation/machines due to non-availability of manpower and any machine breakdown.
• Participates in Validation activities like Equipment/Area and Trial/Study/ Pre-exhibit/Exhibit /validation batch activities as per the protocol.
• Maintains c-GMP practices along with documentation in various records.
• Handles minor parametric setting issues in various machines and products.
• Monitors the speed of the machine and output according to the run time.
• Monitors and reports the unauthorized movement of workmen from line.
• Takes up the responsibilities of the immediate supervisor for the section in his absence.
• Helps the section in charge for preparing of SOP and other GMP documents.
• Reports on day-to-day basis activities in SAP system. (If SAP user ID is available)
• Verification/calibration of balances /Timer/Timer Synchronization etc on a daily/monthly or as and when required.
• Participate in machine qualification activities as per Qualification protocol whenever required.
• Check all the calibration/qualification tags of equipment, instruments, or fire extinguishers for their due date from time to time.
• Checking of line clearance during product changeover and batch changeover/ Monitoring of Temperature and RH/Pressure Gradient of the area/area cleaning and disinfections.
• Knowledge and involvement in EHS, SFTI, 6S, ISO 14001 & 13485 activities.
• Fill safety checklist and provide tool box talk training, report Unsafe condition/Unsafe act and Learning incident (Near miss)
• Perform and ensure that activities are carried out as per hazard identification and risk assessment (HIRA) and site EHS procedure (SEP).
• Provide training to the subordinates as and when required.
• Any other activity from time to time that his supervisor/company feels appropriate.