Summary
Overview
Work History
Education
Skills
Audit Faced
Electronic System Used
Timeline
Generic
Ravi Shanker

Ravi Shanker

Manager Quality Assurance
Mohali

Summary

Quality Assurance professional with 20+ years of experience in pharmaceutical formulations, specializing in cGMP compliance, regulatory audits, and quality management systems. Proven expertise in batch documentation, process validation, equipment qualification, and product release across oral solid, injectable, and parenteral dosage forms. Skilled in handling USFDA, WHO-GMP, ANVISA, and customer audits, ensuring plants remain audit-ready at all times. Recognized for leading QA teams, training personnel, and driving continuous improvement initiatives while maintaining the highest quality and regulatory standards

Overview

21
21
years of professional experience

Work History

Manager Quality Assurance

M/s Smilax Pharmachem Drug Industries
08.2023 - Current
  • Led QA functions, ensuring strict SOP compliance and cGMP implementation across manufacturing and packaging.
  • Managed the complete documentation lifecycle, including BMRs, BPRs, test data sheets, and key quality documents (SMF, VMP, SOPs, STP, GTP).
  • Oversaw in-process QA, product release, annual product quality reviews, stability studies, and control samples.
  • Reviewed and approved change controls, deviations, and ensured timely closure with effective CAPA.
  • Conducted SOP compliance training, periodic self-inspections, and ensured continuous audit readiness.
  • Prepared audit responses and compliance reports, ensuring successful customer and regulatory inspections.

Deputy Manager Quality Assurance

M/s Mankind Pharma Limited, Unit- 3
06.2017 - 06.2023
  • Oversaw in-process QA activities, ensuring cGMP compliance in parenteral and oral solid dosage manufacturing and packing.
  • Managed document control, including SOPs, BMR/BPR, test data sheets, and archival of GMP documents.
  • Coordinated with Technology Transfer and R&D, supporting RA for regulatory filings, and timely submission of documents.
  • Led the review and approval of deviations, change control, CAPA, stability protocols, and annual product quality reviews.
  • Supervised equipment/facility qualification, staff training, training calendar, and self-inspections across departments.
  • Handled audits (USFDA, customer, regulatory), market complaint investigations, product recalls, and compliance reporting.

Manager Quality Assurance

M/s Ind-Swift Limited
12.2005 - 05.2017
  • Monitored IPQA activities for multiple dosage forms (tablets, capsules, dry syrup, ointment, injections), ensuring SOP, cGMP, and GDP compliance.
  • Reviewed executed BMRs, BPRs, deviations, CAPA, change control, and process validation protocols/reports.
  • Investigated market complaints and prepared master BMRs/BPRs to support product quality.
  • Managed product release operations and ensured compliance with licensing requirements (Drug License renewal, WHO-GMP, COPP, GLP, GMP, etc.).
  • Handled vendor qualification, including audits, assessments, and vendor list preparation.
  • Reviewed and approved product artwork updates in line with pharmacopoeia standards and product licenses.

Trainee – Regulatory Affairs & Quality Systems

M/s Elder Pharmaceuticals Limited
12.2004 - 10.2005
  • Reported to the Manager – Regulatory Affairs and Quality Systems, supporting QA and RA compliance activities.
  • Oversaw QA control of manufacturing operations for Loan License and Third-Party (LL & TP) products across multiple sites.
  • Conducted audits of new manufacturing sites, and submitted reports to RAQS management.
  • Ensured all documentation was completed and maintained according to regulatory requirements.
  • Coordinated with marketing to meet documentation and compliance needs within specified timelines.

Education

Master of Science - Organic Chemistry

Bhim Rao Ambedkar Bihar University
01.2001

Skills

  • Quality Assurance & cGMP Compliance – Expertise in ensuring product quality through strict adherence to cGMP, GDP, and SOPs across all operations
  • Quality Management Systems (QMS) – Skilled in managing Change Control, Deviation, CAPA, APQR, and regulatory documentation
  • Regulatory Audit & Compliance – Proven experience in handling USFDA, WHO-GMP, ANVISA, and customer audits with successful compliance outcomes
  • Batch Documentation & Process Validation – Strong command over BMR/BPR review, process validation, equipment qualification, and stability studies
  • Leadership & Team Training – Experienced in leading QA teams, conducting training, and driving continuous compliance culture
  • Cross-Functional Collaboration – Effective coordination with Production, QC, R&D, and RA for smooth technology transfer and regulatory submissions

Audit Faced

  • Successfully faced multiple USFDA audits (3 times) and FDA consultant audits (Parexel, Parul Patel, Rob Walker).
  • Experienced in handling ANVISA (Brazil), WHO-GMP, and customer audits from leading pharma companies including Dr. Reddy’s, Lupin, Sun Pharma, Glenmark, Blue Point, and other non-regulated market audits.

Electronic System Used

  • Caliber QAMS – Change Control, Deviation, CAPA management.
  • Nichelon5 – Training management system.
  • DMS (Document Management System) – SOPs, Specifications, STP/GTP preparation and archival.

Timeline

Manager Quality Assurance

M/s Smilax Pharmachem Drug Industries
08.2023 - Current

Deputy Manager Quality Assurance

M/s Mankind Pharma Limited, Unit- 3
06.2017 - 06.2023

Manager Quality Assurance

M/s Ind-Swift Limited
12.2005 - 05.2017

Trainee – Regulatory Affairs & Quality Systems

M/s Elder Pharmaceuticals Limited
12.2004 - 10.2005

Master of Science - Organic Chemistry

Bhim Rao Ambedkar Bihar University

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Ravi ShankerManager Quality Assurance