Piramal Pharma

CDMO and hospital generics, consumer health

Executive - Production

Machine & Process OperationConfirmed live in the last 24 hours

Full-timePithampur Industrial Area, Pithampur, Madhya Pradesh, IndiaNo salary listedIn-person

About the Job

Requirements

Knowledge of c-GMP practices, safety and hygiene requirements, and GMP documentation.
Knowledge of production operations in the granulation area, including weight verification, product recipe selection, machine setting, spray-rate checks, and in-process checks.
Ability to review batch manufacturing records and quality documents and document process parameters in accordance with ALCOA+ principles.
Ability to address minor machine and product parameter-setting issues and monitor equipment speed and output.
Knowledge of validation, equipment and area qualification, calibration, line clearance, batch and product changeovers, environmental monitoring, cleaning and disinfection, and equipment qualification records.
Knowledge of EHS, SFTI, 6S, ISO 14001, ISO 13485, hazard identification and risk assessment, and site EHS procedures.
Ability to use SAP when a user ID is available.

Responsibilities

Supervise granulation production activity to ensure quality products are manufactured in compliance with c-GMP, safety, and hygiene requirements on a shift-to-shift basis, while maintaining discipline and productivity.
Allocate workmen to different workstations for each shift.
Supervise line operations, including weight verification, product recipe selection, machine setting, spray-rate checks, and scheduled in-process checks at the start of and during coating operations.
Review batch manufacturing records and other quality documents.
Record process parameters, batch manufacturing records, and GMP documentation in accordance with ALCOA+ principles.
Prevent operational or machine stoppages caused by unavailable manpower or machine breakdowns.
Participate in equipment and area validation, trials, studies, pre-exhibit and exhibit activities, and validation batches according to protocols.
Maintain c-GMP practices and documentation in required records.
Monitor machine speed and production output against runtime, and report unauthorized movement of workmen from the line.
Assume the immediate supervisor's responsibilities for the section when that supervisor is absent.
Assist the section in charge with preparing standard operating procedures and other GMP documents.
Report daily activities in SAP when a user ID is available.
Verify and calibrate balances and timers, including timer synchronization, as required.
Participate in machine qualification activities according to qualification protocols.
Check due dates on calibration and qualification tags for equipment, instruments, and fire extinguishers.
Check line clearance during product or batch changeovers and monitor area temperature, relative humidity, pressure gradients, cleaning, and disinfection.
Participate in EHS, SFTI, 6S, ISO 14001, and ISO 13485 activities.
Complete safety checklists, deliver toolbox talks, report unsafe conditions, unsafe acts, and learning incidents or near misses.
Ensure activities follow hazard identification and risk assessment requirements and site EHS procedures.
Provide training to subordinates as required.

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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.

Key Roles/Responsibilities (Supervisor-Granulation Area) :

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.

About the Company

Piramal Pharma

CDMO and hospital generics, consumer health

Piramal Pharma is a diversified pharmaceutical group with three divisions: Piramal Pharma Solutions (PPS), Piramal Critical Care (PCC), and the Consumer Products Division (CPD). PPS operates as a contract development and manufacturing organization, providing development and manufacturing services across the drug lifecycle for clients in North America, Europe, and Asia through a globally connected network. PCC specializes in complex hospital generics, particularly inhaled anesthetics, serving markets in the USA, Europe, and over 100 countries. CPD leads consumer healthcare in India with brands such as Littles, Lacto Calamine, i-pill, Tetmosol, Polycrol, and Tri Activ, and the company serves pharmaceutical companies, hospitals, and consumers by leveraging its manufacturing scale and distribution network.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Maharashtra, India
Founded: 2020

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