Profile: Total more than 10 years of rich and extensive working experience. Worked in site QA, Corporate QA as well as Global QA. Currently working as Assistant Manager in Global Quality GMP Auditing team of STADA Pharma, Navi Mumbai (group of STADA Arzneimittel AG Germany). Global Quality GMP Audits- External and Internal audits. Audit and Compliance. Quality Unit management. Proficient in reviewing the operational practices, identifying the areas of obstruction / quality failures, and advising on system and process improvement. Data Integrity review. Successfully handled various regulatory inspection- USFDA, UK MHRA, EU GMP and ROW inspections. Conducted more than 160 supplier audits across the globe in STADA. Currently responsible for corporate internal audits, inspection readiness and regulatory inspection support, audit, and compliance of STADA own manufacturing sites located across the globe. Language expertise: English, Hindi, Marathi, and Urdu. Based in Mumbai.
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