02 Oct
|
Sun Pharmaceutical Industries
|
Vadodara
02 Oct
Sun Pharmaceutical Industries
Vadodara
Job Title:
Sr.Executive - R&D; Quality CMC QA_Biotech
Business Unit:
Global Quality & Compliance
Job Grade
G11B
Location :
Baroda
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an setting where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Position Summary
To provide independent quality review and oversight of CMC development and technology transfer activities, ensuring that development data, processes, and documentation are compliant, scientifically robust, and fit for technology transfer, regulatory submissions and commercial manufacturing readiness.
Key responsibilities:
• Provide quality oversight for Chemistry,
Manufacturing & Controls (CMC) activities within Biotech R&D; to ensure compliance with global internal quality standards and regulatory requirements.
• Review and approve CMC development documents, including Product Development Reports, Process Development Reports, Product Quality Risk Assessments, process characterization studies, control strategies, specifications, and regulatory supporting documents.
• Conduct independent quality review of upstream and downstream process development data to ensure scientific integrity, completeness, traceability, and compliance with applicable quality requirements.
• Support technology transfer process by performing quality review and approval of technology transfer protocols, reports, batch records, comparability assessments, and associated technical documentation.
• Ensure data generated during development, scale-up, engineering and submission batches are accurate, complete, and comp
📌 Senior Executive R&D Quality CMC QA (Vadodara)
🏢 Sun Pharmaceutical Industries
📍 Vadodara