SHAIK FAKRUDDIN

Engineering Lead with 19 years of experience in Maintenance and Projects within reputed pharmaceutical organizations, specializing in injectable (Aseptic and TS) and oral dosage forms. (Vials, Ampoules, Vials, PFS,, Lyophilization process, tablets and capsules. ( General injectables and Oncology ) Proven track record in ensuring regulatory compliance, optimizing plant reliability, and leading cross-functional teams to deliver the output, Adept at preventive and predictive maintenance strategies, equipment qualification, and continuous improvement initiatives that enhance productivity and GMP standards. Strong expertise in managing CAPEX projects, utility systems, and digitalization-automation upgrades to support business growth and operational excellence. About 19 years’ experience successfully handled regulatory audits like USFDA, MHRA, TGA, ANVISA ,INFARMED, HEALTH CANADA and other customer audits