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Instructor Profile

Jaya Bhalekar

Implementation of Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP). ● Expertise in GMP and GLP with reference to Sterile Process Operations. ● Good exposure on national and international regulatory requirements. ● Expertise in SOP Preparation, Internal audits, Inter-Laboratory programs and Documentation. ● Good exposure in maintaining microbiological cultures (ATCC / NCTC). ● Strong in Microbiological assays for Antibiotics and Vitamins. ● Microbial Limit Test for Identification and Determination of Microbiological Contaminants in Water, Food and Beverages and Pharmaceuticals. ● Pharmaceutical Tests - Sterility, BET. ● Challenge Tests, Preservative Efficiency Tests. ● Microbial Trend Analysis. ● Good exposure on regulatory guidelines from BP, IP, USFDA, USP and EP, 21 CFR, ISO 9001:2015, ISO 14001:2015, ISO 19011:2018, Quality 4.0 Technologies / Methodologies.

About Me:

  • Experiences:
    Jaya offers expertise in quality and compliance across multiple markets, ensuring that you receive quality advice and support throughout the process. She is a result oriented, agile and progress-focused Quality Professional with a 28+ years of long-standing background in the Pharmaceutical and FMCG Manufacturing Industry. With a track record of initiative and dependability, she has devised strategic initiatives which will be valuable to the customers / students. Throughout the course of her past three decades of career, she has mastered my skills in Quality Management System Designing and Implementation, Green-Field Projects Commissioning and Qualification and Statutory / GMP Compliance / Continuous Improvement Projects and Internal & External Audits, that have contributed to Quality Excellence, Customer Satisfaction and Sustainable Business Results. She has practical experience of working closely with the Organizations Internal and External Interested Parties / Stakeholders (Both Domestic and International Stakeholders). She has a proven ability to lead, manage and motivate people with a variety of skill sets and to work effectively in an international multicultural matrix organization.