Pradeep Kumar Mishra
Sr. Manager QMS/Validation/CSV/IT/Qualification Assurance, ||Ex DRL, SNC Lavalin, NNE, Reliance LifeSciences|| Manufacturing and Consulting in pharma and Biologics ||
- Role
- Qms Validation Csv IT Qualification Assurance Remediation Risk Assessments Biotechnology at Glenmark Pharmaceuticals
- Location
- Charlotte, NC, US
- LinkedIn followers
- 500 followers
About Pradeep Kumar Mishra
Completed Implementation of Risk Based Qualification for Facility Project for Injectable plant at Dr. Reddy\'s Lab Vizag with Prefilled syringe line & Vial Line handled in Isolator.Qualification based on ASTM E2500-07, ISPE Guide, ICH Q8,9,10, Vendor Qualification for suitability of vendor data to leverage Qualification.Guidance to team to implement Verification plans instead of IQ/OQ. Experience in Implementing the Quality Management System for cGMP Requirement & ISO Certification for Quality.Change management and orientation of Procedures & Employee for Quality in Service & Manufacturing.Associate Membership for American Society for Quality(ASQ).Enriched experience of Biopharma in Projects, Validation & QA in a rapidly evolving regulations & requirements, Keeping a pace with Organizational requirements & Limitations, The basic need for long term survival of any industry is quality as it increases the Productivity & decreases waste, Hence a career chosen to go in depth of Quality & Benefit Industry with my experience.Specialties: Quality & Compliance, cGMP, Projects, Six sigma Projects, audits,Trainings.
Experience
Qms Validation Csv IT Qualification Assurance Remediation Risk Assessments Biotechnology
Dec 2022 — Present · Hyderabad, IN
Education
Welingkar Institute of Management
Post Graduate Diploma in (Operations), Business Administration
2009 — 2011
Kendriya Vidyalaya
12th, Physics,Chemistry, Biology
1987 — 2000
Indian Institute of Technology, Delhi
Certificate course - Six Sigma Green Belt, Six sigma
2013 — 2014
Birla Institute of Technology and Science, Pilani
M.S., Quality Management
2010 — 2012
Doctor Bhim Rao Ambedkar University
Bachelor of Engineering (B.E.), Biotechnology
2003 — 2007
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