Senior Executive-QA

Piramal Pharma Limited; Hinoba-an; On-site; PHP 350,000 - 550,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Executive-QA to oversee IPQA activities, sampling, line clearance, calibration, and shop-floor compliance. The role emphasizes data integrity, EHS adherence, and documentation to ensure batch release readiness.

You will monitor in-process control, perform IPQA tests, review line clearances during product changes, and train new employees while maintaining quality standards across manufacturing and packaging operations.

Qualifications

• IPQA activities include sampling, line clearance, calibration, and shop floor compliance.
• Ensure data integrity compliances at site and during activities.
• Support EHS activities and report near misses as required.
• Monitor product quality, in-process control, and manufacturing environment.
• Review and approve batch manufacturing, packaging documents and QA records.
• Train new employees on systems, procedures, and competency development.

Responsibilities

• Implement systems and procedures per cGMP/ISO 13485 on shop floor.
• Maintain data integrity and documentation for quality compliance.
• Oversee EHS-related activities and incident reporting.
• Perform IPQA sampling and testing across processes.
• Review batch records and approve changes in line clearance.

Job description

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 Senior Executive-QA

Job Description IPQA activities like Sampling ,Line Clearance, Calibration, Shop floor Compliance etc.

Key Roles and Responsibilities

• Ensure effective implementation of system and procedure as per cGMP, ISO 13485 in shop floor, warehouse and engineering along with documentation.
• To ensure data integrity compliances at site and while performing activities.
• To ensure the EHS (Environment, Health and Safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as observed as per EHS requirement.
• Monitoring of product quality, in-process control and manufacturing environment.
• To perform AQL and in process test for manufacturing process as well as packing stage.
• Approval of line clearance during product changes over/ Batch change over.
• Sampling of Pooled samples, Micro sample, FG control samples, stability samples and other samples as per requirement along with related documentation.
• To perform calibration of IPQA instrument.
• Training of new employees, system practices and procedure to develop competency.
• Review and approval of executed batch manufacturing, packaging documents & other quality documents.
• Online stage wise BMR/BPR review.
• Responsible for alarm/audit trail review and trending of alarm as and when required.
• Handling of material on shop floor through approval for MRN, LRN, and MRQN.
• Submission of In-process analysis report from QC to production after review.
• Handling of non-conformance and Line failure activity along with related documentation.
• Handling of Ensur, SAP & trackwise activity as per Quality Assurance procedure.
• Handling of QAAS, CPV, and CLEEN software.

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.

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.