Nikhil Kumar

Experience

• 

  Wockhardt Ltd.

  Jan 2015 - Jul 2015

  Apprentice

  QA at Packing Operations (Solid Orals)Process Performance Qualifications

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  SUN PHARMA

  Aug 2015 - Aug 2017

  Quality Assurance Officer

  1.In-Process Quality Assurance Manufacturing General & Sex Hormone Block (Tablet, Capsule)2. In-Process Quality AssurancePacking (Blisters, Strip, Bottle, Satchet).3.Process Validation/Qualification report preparation and compilation.4.Contaminant Study (For Similar AHU for two different Manufacturing Areas/Cubicle)5.In-charge APR/PQR.6.Handled Market complaints.

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  Lupin

  Sept 2017 - Oct 2020

  Quality Assurance-Compliance1.Market Complaint Handling 2. QMS Compliance (i) Deviation Handling (ii) Change Control (iii) CAPA (iv) CAPA Effectiveness Monitoring (v) Global CAPA acceptance & implementation (vi) QCM (Quality Council Meeting) with H.O. & CQA (vii) SQCM (Site Quality Council Meeting) CQA (viii) Monthly Report Preparation (Quality) (xi) Corporate Complaince coordinator for Site3. APQR4. Hold Time Study5. Process Qualification/Validation,6. In-charge-IPQA (Managed a team of 10 IPQA's) 7. Artwork Management System (AMS) & Shade Card Approval8. Operational Packing Material List (OPML) Review and Approval9. Document Control and System through SAP10. Batch Release11. Certified Trainer QA Show less Quality Assurance-Compliance1.Market Complaint Handling 2. QMS Compliance (i) Deviation Handling (ii) Change Control (iii) CAPA (iv) CAPA Effectiveness Monitoring (v) Global CAPA acceptance & implementation (vi) QCM (Quality Council Meeting) with H.O. & CQA (vii) SQCM (Site Quality Council Meeting) CQA (viii) Monthly Report Preparation (Quality) (xi) Corporate Complaince coordinator for Site3. APQR4. Hold Time Study5. Process Qualification/Validation,6. In-charge-IPQA (Managed a team of 10 IPQA's) 7. Artwork Management System (AMS) & Shade Card Approval8. Operational Packing Material List (OPML) Review and Approval9. Document Control and System through SAP10. Batch Release11. Certified Trainer QA12. Vendor Qualification (VQG) Show less

  • Executive Compliance QMS & Investigation Lead-Quality

    Jun 2020 - Oct 2020

  • Compliance QMS & Investigation Lead-Quality

    Sept 2017 - Jun 2020
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  Ajanta Pharma Ltd

  Oct 2020 - Sept 2021

  QMS Complaince and Investigation lead-Quality

  Quality Assurance-Compliance1.Market Complaint Handling 2. QMS Compliance (i) Deviation Handling (ii) Change Control (iii) CAPA (iv) CAPA Effectiveness Monitoring (v) Global CAPA acceptance & implementation (vi) QCM (Quality Council Meeting) with H.O. & CQA3. Self inspection4. QRM specialist5. Process Qualification/Validation 6. SAP Transaction (All activity related to QA)7. Batch Release8. Certified Trainer QA

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  Dr. Reddy's Laboratories

  Sept 2021 - Feb 2024

  Assistant Manager - Audit and QMS Compliance at Dr. Reddy Laboratories Ltd (FT0-3), Hyderabad

  Having diversified experience in handling Regulatory bodies like (USFDA/MHRA/TGA/WHO/ANVISA/EU etc.)1. Regulatory Audits, Coustomer Audits & Internal Audits (Self inspection).2. Quality Management System (QMS) (a) Deviation/Incident (b) CAPA (Site Specific and Global CAPA implementation) (c) Change Control (Fiori) (d) Quality Risk Assessment (QRM) (e) Market Complaint/FAR/Recall (f) Investigation Lead (CFTM-Quality)3. Hand on experience on software's like SAP, Caliber QAMS, Caliber LIMS, e-Log, e-DMS, SABA ,TRIMS, ICMS.4. E-Batch Records (BMR's and BPR's-MES- PAS|X)5. Engineering QA Reviewer.6. Process Qualifications.7. Have experience in New Facility/Equipment Qualifications for OSD formulation unit.8. Site & Corporate (BU) Quality review meeting coordinator.9. Technical Agreement Show less

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  Biological E. Limited

  Dec 2023 - now

  Assistant Manager -Audit and QMS Compliance Specialist

  Senior Audit and Compliance Specialist