Title: CMO Quality Audit Lead
Job Title: |
CMO Audit Lead |
Business Unit: |
Global Quality & Compliance |
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Job Grade |
G7 (General Manager) |
Location : |
Mumbai |
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At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment 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.”
Job Summary:
To plan and execute quality audits of Global CMO, CWH/CNF, Aseptic consumable suppliers as per the audit program (Routine, Qualification & For Cause audits) to ensure maintenance of Quality Standards in compliance to cGMP and regulatory requirements. Key Responsibilities :
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Travel Estimate |
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Job Requirements |
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Educational Qualification |
M.Sc (Microbiology) |
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Experience |
Tenure: QC / QA Professional in Microbiology & Quality Assurance with 20 to 22 years of experience in microbiological sciences, cGMP/GLP, pharmaceutical product test methods development and validation; Document / Process gap assessment, Quality Assurance and Regulatory as well as Pharmacopeia Compliance. Processes Known: Aseptic Processing, Terminal Sterilization, BFS Technology, Lyophilization, Prefilled Syringes, Oral Solid Dosages, Oral Liquids, Oral Powders & API. Certified by Indian FDA for microbiological and sterility testing.
Maintenance of cGMP; Developing, updating and reviewing Quality Systems; Root Cause Investigations, Implementation of CAPA activities; OOS/Deviation Management; Compliant Handling, Aseptic Process Simulation and Process Optimization.
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Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!
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Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). |