Vikas Mehra

About Vikas Mehra

Highly dedicated self-motivated individual having over +27 years of experience in pharmaceutical industry in Formulations and API as Quality professional in various discipline like Quality Assurance, Quality Control, Stability Management and Analytical Research The experience spans over working with multinational organizations within India and abroad. I have strong inclination to implement or enhance Quality System Management based on Risk approach thereby to reduce business risk due to regulatory Non-compliance. My academic background of Master degree in Pharmaceutical Sciences compliments various aspects of pharmaceutical business including Analytical Research, Quality, Data Integrity and Laboratory Systems. My academic and experience gives me an edge over understanding both API as well as Formulations. Proven track record of handling multiple regulatory inspections with positive outcome. Handled various agencies like USFDA, EDQM, MHRA, TGA, SAHPRA, WHO, PMDA and HEALTH CANADA as Senior Quality Leader Subject Matter Expert in designing Quality Systems to curb Data Integrity concerns cited by various regulatory agencies and successfully implemented Consent Decree remediation plan with approval from USFDA and resuming supplies to US Subject Matter Expert in designing Digitalization concepts and its implementation Ensured Continuous surveillance of all manufacturing sites to evaluated and assisted in inspection readiness at all times and trained employees on handling of regulatory inspections

Experience

1. Head of Quality Ibap (India,bangladesh,africa,pakistan)

   Centrient Pharmaceuticals

   Oct 2021 — Present · Chandigarh, IN

   Currently working as Head of Quality IBAP (India,Bangladesh,Africa,Pakistan)\\\\n Responsible for multiple locations including Beta-lactam manufacturing facility.\\\\n Designed Strategy for Beta-lactam containment\\\\n Successfully completed TGA audit and closure with no critical observations\\\\n Designed remediation program for OAI/WL status during last USFDA inspection in 2018.\\\\n All CAPA related to remediation program were completed and implemented within record time of 8 months\\\\n Key role in drafting Quality procedures for the organization for all manufacturing sites across Europe, Mexico and China\\\\n Key role in designing and implementation of Computer System Validation Program. More than 90% CSV is completed under my supervision\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Education

• Panjab University,Chandigarh

  Master's degree, Pharmaceutical Sciences

  1994 — 1996

• Panjab University,Chandigarh

  Bachelor's degree, Pharmaceutical Sciences

  1990 — 1994