Executive - Quality Assurance

Piramal Pharma Limited; Hinoba-an; On-site; PHP 400,000 - 800,000; Full time

Job summary

Piramal Pharma Limited, a global CDMO, is seeking an Executive - Quality Assurance to reinforce QEHS compliance across manufacturing, packing and dispensing areas.

You will perform area and line clearance, in-process checks, batch record verification, environmental monitoring, data integrity controls and CAPA-driven improvements for both domestic and export markets.

Responsibilities

• Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
• In process checks in Manufacturing and Packing activity.
• Daily verification of weighing balance calibration activity.
• Daily verification of environmental monitoring of raw material staging area and Manufacturing and Packing area.
• Verification of each equipment cleanliness and area cleanliness during line clearance
• Verification and review of online Batch Manufacturing Records.
• Sampling of bulk stage and finished goods analysis and control sample.
• Verification of production documents.
• Daily nonconformance observation reported and maintained.
• In process quality checks in Tablet, Liquid, HNH, ANH manufacturing dept.
• Line Clearance for Manufacturing, Packing & Dispensing activity.
• Sampling of validation samples (Process, Packaging & Cleaning), rinse & Swab samples
• Review of production records and Finished Goods verification.
• On job training to the new people working in the production area.
• Statistical Process Monitoring.
• Online observation of process deviation and effective implementation of CAPA.
• Reporting of daily nonconformance.
• Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111
• Ensuring avoidance of breach of data integrity in area.
• Implementation of effective sanitation program in area.
• Imparting required training to shop floor personnel.
• Adherence to the requirements of EHS norms.
• Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
• Customer centricity.
• Document Archival.
• To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
• To implement QEHS policy & objectives.
• To ensure participation and consultation of worker.
• Ensure use of PPE
• To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
• To ensure work permit system during maintenance activities.
• To implement QEHS continual improvement projects at site and monitor.
• To ensure disposal of waste.
• Authorised to prevent improper workplace conditions.
• Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
• Authorised to prepare OH&S performance document.
• Authorised to conduct training of workmen’s related to OHSMS.
• Review & handling of market complaint ensuring the quality and integrity of all GXP data and documentation generated.

Job description

Company Overview

Be the First to Apply 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 - Quality Assurance

Job Description

Job Description JD- Executive (IPQA)

• Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
• In process checks in Manufacturing and Packing activity.
• Daily verification of weighing balance calibration activity.
• Daily verification of environmental monitoring of raw material staging area and Manufacturing and Packing area.
• Verification of each equipment cleanliness and area cleanliness during line clearance
• Verification and review of online Batch Manufacturing Records.
• Sampling of bulk stage and finished goods analysis and control sample.
• Verification of production documents.
• Daily nonconformance observation reported and maintained.
• In process quality checks in Tablet, Liquid, HNH, ANH manufacturing dept.
• Line Clearance for Manufacturing, Packing & Dispensing activity.
• Sampling of validation samples (Process, Packaging & Cleaning), rinse & Swab samples
• Review of production records and Finished Goods verification.
• On job training to the new people working in the production area.
• Statistical Process Monitoring.
• Online observation of process deviation and effective implementation of CAPA.
• Reporting of daily nonconformance.
• Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111
• Ensuring avoidance of breach of data integrity in area.
• Implementation of effective sanitation program in area.
• Imparting required training to shop floor personnel.
• Adherence to the requirements of EHS norms.
• Execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
• Customer centricity.
• Document Archival.
• To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
• To implement QEHS policy & objectives.
• To ensure participation and consultation of worker.
• Ensure use of PPE
• To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
• To ensure work permit system during maintenance activities.
• To implement QEHS continual improvement projects at site and monitor.
• To ensure disposal of waste.
• Authorised to prevent improper workplace conditions.
• Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
• Authorised to prepare OH&S performance document.
• Authorised to conduct training of workmen’s related to OHSMS.
• Review & handling of market complaint ensuring the quality and integrity of all GXP data and documentation generated.

Company Information

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.

Equal Employment Opportunity Statement

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment 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.