Jitendra Kumar Yaba Email & Phone Number

1. Having 13 years of rich experiences in Quality Assurance in reputed Pharma organizations.2. Exposed and successfully faced Regulatory Inspections Audits like USFDA (8 times), WHO (3 times), MHRA (4 times), TGA (2 times), GCC, ENVISA and MNC coustmers (Mylan, GSK, Sandoz, Abbott etc.) for Solid Oral (Tablet and Capsules), Semisolid (Ointment, Gel, Cream, Topical Solution), MDI and DPI formulation3. Expertise in Quality Mangement system (Change Controls, Deviation, CAPA, OOS, OOT, IP-OOS, Market Complaints etc.)4. Acquired Key skills on QMS designing, Implementation, controlling and maintenance, Process Quality Assurance, Equipment and Area Qualifiation, Process validation, Quality Risk assessment.5. Qualified Trainer for GMP guidlines as per Regulatory Amendments and conducting training for various quality modules.6. Expertise in Computer system Validation and review of Audit trails. Performed more than 700+ cross functional GxP equipments QRM for not performing CSV activity in GMP enviornmnet.7. Expertise in GAP assessment for all GxP computerized systems through Quality Risk assessment and make compliance as per 21 CFR part 11 and GAMP 4 Guidlines.8. Well versed with QAMS, EDMS, DMS, SAP, SABA etc.

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  Kendriya Vidyalaya

  First Class