JOHNSON J

Experience

• 

  Granules Pharmaceuticals, Inc.

  Aug 2007 - Nov 2008

  Quality Control Inspector

  1.Conducting Stabiity studies 2.Stability testing planning and withdrawn 3.Quality control - Dissolution specialist4.work assignation and review of wet analysis 5.protocol preparation

• 

  Dr. Reddy's Laboratories

  Dec 2008 - Dec 2014

  Senior Team member (Junior Manager)

  1.Leading cleaning validation team, 2.Execution of method Transfer related activities.3.Potent drug analysis and investigations.4.IP / FP - HPLC Specialist5.Analytical Techniques/ cGMP / cGLP6.Handling of Cardio vascular , Immuno suppresent Drugs.7.Audits - WHO , FDA

• 

  Teva Pharmaceuticals

  Dec 2014 - Aug 2021

  1.GMP Manufacturing & Quality 2.Evaluation of Investigations 3.CAPA and Change control 4.21 CFR part 115.Investigating the Non confirmities 6.Risk Assessment and Risk Management.7.Review of Quality Reports and escalating the discrepancy observed.8.Stability studies9.Data Integrity and compliance.10. 21 CFR compliance.11.Conducting Trainings.12.Evaluation of Out of Specifications and Out of Trend quality reports.13.Effective communicator and Team Management skills Show less

  • Quality Management Specialist - QC

    Oct 2019 - Aug 2021

  • Senior Executive ONSITE

    Jul 2018 - Oct 2019

  • Complaint Handling

    Mar 2017 - Jul 2018

  • sr.executive

    Feb 2016 - Mar 2017

  • Senior Quality Analyst

    Dec 2014 - Feb 2016
• 

  HCLTech

  Sept 2021 - now

  ☆ Collaborating with senior leadership andclients to align business Targets and Servicelevel agreements (SLA) .☆Having Good exposure in setting up Qua-lity standards.☆Proven record in extensive leadership andsetting up continues process improvements.☆Experienced in Quality , QA activitiesand process Audits.☆Expertise in handling of Supplier correctiveaction request (SCAR), Change control /Change Request andimplementing corre-ctive and preventive actions (CAPA) .☆Program/Program Management and enha-nced associate performance through dailyMonitoring.☆ Medical Devices Complaint Handling ☆ Billing and PMO☆ Project , supplier , ISO Audits☆ power review and Governance meetings Show less

  • Senior Manager

    Aug 2023 - now

  • Project Quality Manager

    Sept 2021 - Jul 2023