Technical Staff

Piramal Critical Care, Inc.; India; On-site; INR 300,000 - 480,000; Full time

Job summary

Piramal Pharma Solutions in India is seeking a Technical Staff for the Inspection Department to ensure cGMP compliant documentation across shifts. You will allocate work, supervise line operations, review BMRs and QA records, and support validation activities while maintaining ALCOA+ and EHS standards.

Responsibilities include calibration checks, line clearance during changeovers, and reporting through SAP where applicable; you may train subordinates and assist the section in charge as needed.

Responsibilities

• activities of the inspection department on a shift-to-shift basis to complete documentation in accordance with cGMP requirements.
• Allocates workmen for different workstations on a shift-to-shift basis.
• Supervise/Line operations like weight verification,Tablet counting,Light intensity by lux meter,Challenge test /Camera teaching etc.in inspection area.
• 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 /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/Thickness gauge/S S Tablets/Lux meter etc on 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.

Job description

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
activities of the inspection department on a shift-to-shift basis to complete documentation in accordance with cGMP requirements.

Key Roles/Responsibilities (Inspection Area) :

• activities of the inspection department on a shift-to-shift basis to complete documentation in accordance with cGMP requirements.
• Allocates workmen for different workstations on a shift-to-shift basis.
• Supervise/Line operations like weight verification,Tablet counting,Light intensity by lux meter,Challenge test /Camera teaching etc.in inspection area.
• 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 /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/Thickness gauge/S S Tablets/Lux meter etc on 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.