Technical Staff

Piramal Pharma Limited; Hinoba-an; On-site; PHP 167,000 - 257,000; Full time

Job summary

Piramal Pharma Limited is seeking a Technical Staff to support manufacturing operations at the Hinoba-an site. You will allocate workmen across workstations on a shift-to-shift basis, supervise line operations, verify weights, set machine parameters and maintain ALCOA+ documentation.

You will review batch manufacturing records and GMP documents, participate in validation activities, monitor process speeds, ensure c-GMP practices, and report daily activities in SAP while prioritizing safety and

Qualifications

• ALCOA+ principles followed in documentation.
• Knowledge of GMP documentation and batch records.
• Experience in manufacturing line operations.

Responsibilities

• Allocates workmen for different workstations on a shift-to-shift basis.
• Supervise/Line operations like weight verification, product recipe selection, machine setting, initial parameter setting, in-process check.
• Review the batch manufacturing record and other quality documents; fill in process parameters, BMR and GMP documents/records as required.
• Participates in Validation activities like Equipment/Area and Trial/Study/Pre-exhibit/Exhibit/validation batch activities as per protocol.

Skills

SAP

Job description

Job Title

Technical Staff

About the Company

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

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL's associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

Responsibilities

Allocates workmen for different workstations on a shift-to-shift basis. Supervise/Line operations like weight verification, Product recipe selection ,machine setting,Initial parameter setting, initial parameter checking, In-process check as per frequency, Challenge test of product with machine, metal detector challenge test, Rejection verification challenge test etc at start/during compression/capsule filling 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/Load cell/Encoder/Filling depth/ timer Synchronization/ checkweigher calibration 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.

Allocates workmen for different workstations on a shift-to-shift basis. Supervise/Line operations like weight verification, Product recipe selection ,machine setting,Initial parameter setting, initial parameter checking, In-process check as per frequency, Challenge test of product with machine, metal detector challenge test, Rejection verification challenge test etc at start/during compression/capsule filling 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/Load cell/Encoder/Filling depth/ timer Synchronization/ checkweigher calibration 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.

Equal Employment Opportunity

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.