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Piramal Pharma Ltd

Senior Executive-QA

Piramal Pharma Ltd Ahmedabad, Gujarat, India

Pharmaceutical Manufacturing · 1,001-5,000 employees

Yesterday
qa Senior (5-10 yrs) Full-time India
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About the role

The Senior Executive-QA is responsible for managing document control, archival processes, and ensuring GMP compliance within the pilot plant. They oversee sampling activities, line clearance, and the review of batch manufacturing and packaging records to maintain quality standards.

What they look for

Quality Assurance GMP Document Control Batch Manufacturing Records SOP Preparation Data Integrity Quality Management System Sampling Line Clearance Archival Management Compliance Training Delivery Logbook Maintenance Change Control Deviation Management OOS

Requirements

The role requires expertise in Quality Management Systems, including the preparation of SOPs and the management of quality events like deviations and change controls. Candidates must possess a strong understanding of data integrity and experience in monitoring GMP-compliant operations.

Full description

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Division

Piramal Pharma SolutionsPiramal 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-QAJob 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.

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