Results-driven highly skilled quality professional with extensive auditing experience in 10+ countries including US, Europe, China, India & Korea. Certified Quality Auditor and adept to maintain scores of suppliers, pharmaceutical facilities, R&D and CMO. Exceptional grasp on GMP, GCP & GDP.

Experience

  • Head QA / Quality Auditor

    at Novugen Pharma-Malaysia

    December 2016 - at Present

    Selangor

    Accepting audit assignments, Travel Scheduling, Defining Agenda, Performing audit pre-work, Conducting audits and ensuring post-audit activities are completed within defined time frames. Adept at assessing regulatory risks through audits, Mentoring fellow auditors, Failure investigations, Supplier Corrective Action Requests (SCAR) and Facilitating product release. Key Contributions:  More than 50+ GXP Auditing, Vendor qualification, CMO qualification  Institutionalized Technical Agreement and Quality Agreement formats to safeguard the business interest  Implemented Supplier Balanced Scorecard (BSC) for API & Excipient vendors in China, India & Europe.  Improved quality scores of CMOs in the USA, ASEAN, and India to save overall 5-10% against the budgeted cost.

  • Deputy General Manager-QA

    at Aurobindo Pharma Ltd

    September 2014 - August 2016

    Hyderābād - Telangana

    Administered QA operations, quality audits, delivering excellent outcomes for CAPA, Investigations, Training, APQR, Regulatory Compliance (USFDA, EUGMP, WHO & ROW) and validations/qualification of the manufacturing plants. Managed all aspects of GMP/GDP Audits, Investigations, OOT/OOS, CAPA, SCAR, Change Requests, Complaint Control, Transport-validations, Technical Training, and Quality Agreements. Created a sustainable quality culture for a team of 250 people. Key Contributions:  Served in capacity of Site QA In-Charge and successfully passed USFDA,MHRA and EUGMP inspections.

  • SAssistant General Manager-QA

    at Torrent Pharma Ltd

    February 2011 - August 2014

    East - Sikkim

    Established an efficient and effective QA system for the plant, warehouse ,and distribution centers.

Education

  • Certified Quality Auditor

    at American Society of Quality

    2018 - 2018 (1 year)

  • Ph.D. (Doctor of Philosophy)

    at Sikkim Manipal University

    2013 - 2018 (5 years) East - Sikkim

  • Six Sigma Green Belt

    at Indian Statistical Institute

    2014 - 2014 (1 year) Hyderābād - Telangana

  • Master of Science (Chemistry)

    at University pf Delhi

    1994 - 1996 (2 years) New Delhi - Delhi

Services offered

  • Quality Auditing

    Proven history of creating an environment of cohesion, where quality audits add value to the pharmaceutical business. An enabler to create business alliances and execute agreements with vendors and external partners. Proven expertise in:
    • Quality Audit Management (Vendors & CMOs)
    • Audit planning, Reporting & CAPA
    • Quality Risk Assessment & Mitigation
    • GXP Facility Inspections (GMP/GDP/GCP)
    • Driving Regulatory Compliance & Remediation
    • Technical and Quality Agreement Finalization

Hives