Senior Executive-QA

Piramal Pharma Solutions; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions seeks a Senior Executive-QA to oversee document control, archival management, and GMP compliance at our site in Gujarat, India. The role supports QMS activities, prepares SOPs, delivers training, and ensures data integrity across operations.

The incumbent will review batch records, monitor retention samples, and assist with line clearance and control sample management within the Pilot Plant environment.

Qualifications

• Experience in GMP documentation and record-keeping.
• Knowledge of QMS, SOPs, and change control.
• Experience with retention samples, in-process sampling, and batch review.

Responsibilities

• Responsible for document control and archival management, including issuance, retrieval, and maintenance of GMP documents.
• Oversees retention sample storage monitoring, in-process and verification sampling activities, line clearance, and control sample management.
• Reviews batch manufacturing and packaging records to ensure compliance with quality systems and GMP requirements in the Pilot Plant.
• Supports the Quality Management System (QMS) through SOP preparation, training delivery, logbook maintenance, and management of quality events.
• Promotes and ensures data integrity compliance and awareness across site operations.

Job description

Job Description

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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

Senior Executive-QA

Job Description

• Responsible for document control and archival management, including issuance, retrieval, and maintenance of GMP documents. Oversees retention sample storage monitoring, in-process and verification sampling activities, line clearance, and control sample management. Reviews batch manufacturing and packaging records and ensures compliance with quality systems and GMP requirements in the Pilot Plant. Supports the Quality Management System (QMS) through SOP preparation, training delivery, logbook maintenance, and management of quality events. Promotes and ensures data integrity compliance and awareness across site operations.
• Issuance and control of documents. (e.g. SOPs, BMR, BPR, Formats, Logbooks and LNBs).
• Management of Archival and Retrieval of documents.
• Monitoring of temperature for retention sample storage
• In process sampling of Clinical batches, Sampling of Swab during cleaning verification, Line clearance in pilot plant, water sampling, management of control samples.
• To review master and executed Batch Manufacturing Record, Batch Packaging Record and other documents related to manufacturing/packaging activity.
• To ensure practices being followed in Pilot Plant are in compliance with the quality procedures of the site.
• Prepare SOPs related to QA Department.
• Impart Induction Training on topics and on which training has been taken.
• Updating of Logbooks related to QMS documents (change control, deviation, OOS).
• Ensure compliance and awareness of data integrity at site.