Mulka Praveen
Senior Manager Qa Sterility Assurance @Intas Pharmaceuticals
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WORK HISTORY
Senior Manager Qa Sterility Assurance @Intas Pharmaceuticals
Ahmedabad, IN
Leading facility design and compliance oversight for aseptic manufacturing, ensuring cGMP regulations are met to prevent contamination. Developed robust contamination control strategies aligned with regulatory requirements and executed Media Fill Testing programs. Managed Quality Management System elements and facilitated quality review meetings and audits.
EDUCATION
Osmania University
B.Sc. - Microbiology
Bangalore University
M. Sc. Biotechnology - Indian Academy , Biotechnology
ABOUT MULKA PRAVEEN
With over 18 years of esteemed experience in Quality Assurance within the Pharmaceuticals & Biopharmaceuticals industry, specialize in elevating Sterility Assurance and Quality operations for Drug Substance & Drug Product manufacturing. Mastery in evaluating equipment for sterile manufacturing, ensuring compliance with sterility assurance protocols, aseptic techniques, and cleaning processes: Proficient in executing and overseeing aseptic manufacturing best practices. Expertise extends to cultivating clean room behaviors, developing comprehensive training programs, and conducting thorough investigations for process deviations. Recognized for leadership in enhancing quality operations, leading workshops on diverse quality-related topics, fostering employee development and excelling in problem-solving: As a dedicated Quality Partner, possess an exceptional understanding of GMPs, Quality Management Systems (QMS), and documentation requirements in pharmaceutical and biopharma manufacturing. Commitment to upholding the highest standards of quality and safety, ensuring compliance with FDA, EMA, and other regulatory standards. Relentless pursuit of excellence drives contributions to the advancement of pharmaceutical quality assurance practices-
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