Senior Executive - Quality Assurance

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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 - Quality Assurance
Job Description
Responsible for performing Technology Transfer and Process Validation activities in compliance with cGMP requirements. Prepare and review Master Batch Manufacturing Records (MBMR/BMR), Batch Packaging Records (BPR), Process Validation (PV) Protocols, and associated documentation. Coordinate and execute validation-related activities, ensure accurate documentation, and support successful technology transfer and commercial manufacturing processes while maintaining regulatory and quality compliance.
Responsible for performing Technology Transfer and Process Validation activities, including the preparation, review, coordination, and execution of Technology Transfer and Validation protocols in accordance with regulatory requirements, cGMP guidelines, and the Validation Master Plan (VMP).
Key responsibilities include planning and executing technology transfer activities, coordinating with cross-functional departments to ensure successful protocol implementation, monitoring validation activities, and maintaining complete and accurate documentation throughout the project lifecycle.
Prepare, review, and maintain Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), validation protocols and reports, risk assessments, and associated study documentation. Ensure all activities and records are accurate, complete, compliant with regulatory and quality standards, and support continuous improvement initiatives within the validation and technology transfer functions.

Work arrangement
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