Yogin Patel
Assistant Manager - Quality Assurance (Compliance) @Zentiva
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WORK HISTORY
Assistant Manager - Quality Assurance (Compliance) @Zentiva
Ankleshwar, IN
Management of Regulatory inspections (Physical, Distant): Preparation at site, Execution, Explanation to auditors from front end as subject matter expert, Drafting CAPA response & periodic CAPA update and sharing to Inspector/Authority\\\\n- Ensuring the audit readiness and compliance adherence against Global Quality Leading Compliance activities for managing compliance throughout the site as per CDSCO, FDCA, ICH & EU guidelines\\\\n- Executing internal audit (self-inspection) and reporting to the management\\\\n- SAP HANA implementation & Computerized system validation: Successfully led and implemented the project being Business Quality Representative, QM module lead and Organizational Change Manager\\\\n- Problem solving related to SAP HANA and LIMS Interface in cooperation with ITS\\\\n- Management Quality Report compilation & Communication for Pharma and API site. Leading improvement action\\\\n- Harmonizing Quality System procedures across API & Pharma site Providing, Training to End users of SOP/Systems\\\\n- Management of TrackWise as Administrator & SAP QM module as Power User\\\\n- Leading Quality Risk and Recall management at site\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n
EDUCATION
NIPER
Master of Pharmacy, Formulations
Baroda college of Pharmacy
Bachelor of Pharmacy (B.Pharm.), Pharmacy, B
ABOUT YOGIN PATEL
Passionate and Result-oriented professional with firsthand experience in implementation/maintenance of quality compliance programmes to achieve common organizational goals. Self starter and willing to go extra miles to achieve the predetermined goals within set timelines. I am excellent in working with team to achieve certain team goal on time with excellence. Ready to take up new challenges and enlighten the professional career with new innovations in techniques and activities to improve Personnel efficiency and Quality with patient centricity mindset. Have developed expertise in- Validation and Inprocess Quality Assurance - Computerized System Validation - SAP-QM module expert - Quality Management System - Audits & Inspection - Batch record Review and Release - Good Manufacturing Practices - Pharma Regulatory compliance
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