Summary
Overview
Work History
Education
Skills
Certification
Languages
Compliance Standards
Application
Timeline
Generic
Anwar Sulaiman KC

Anwar Sulaiman KC

Hyderabad

Summary

Dynamic and accomplished Pharmaceutical Quality & Compliance professional with 25+ years of proven leadership in regulated life sciences environments. Adept in designing and implementing global compliance programs, ensuring adherence to USFDA, EMA, PMDA, and other international regulatory bodies. Extensive experience overseeing quality systems, risk assessments, internal audits, and data integrity initiatives across manufacturing and laboratory functions. Strong record of managing cross-functional teams, leading regulatory inspections, and driving continuous improvement aligned with international standards.

Overview

25
25
years of professional experience
1
1
Certification

Work History

Sr. Quality Consultant

The Quantic Group
02.2025 - Current
  • Led regulatory compliance initiatives across FDA, EMA, MHRA jurisdictions, including remediation of FDA warning letters and consent decrees.
  • Designed and implemented fit-for-purpose QMS for GxP operations, aligned with ISO 9001 and 27001 standards.
  • Executed internal audits, gap analyses, and inspection readiness programs to ensure global compliance.
  • Enhanced data integrity through risk-based assessments and ensured 21 CFR Part 11 and Annex 11 compliance.
  • Delivered compliance training and mentored junior consultants to embed a strong quality culture.

Vice President – Quality (Cluster Head)

Aurobindo Pharma – Apitoria Division
Hyderabad
07.2021 - 11.2024
  • Developed and led the implementation of corporate quality compliance strategy across multiple manufacturing sites.
  • Directed data integrity and audit trail review programs, ensuring system and process compliance.
  • Successfully managed regulatory inspections from USFDA, EMA, and PMDA with zero critical observations.
  • Implemented LIMS and compliance metrics tracking; drove harmonization of SOPs and quality KPIs.
  • Introduced agile-based process improvement strategies aligned with regulatory and business needs.

Senior General Manager – Head, Quality Control

Hetero Drugs Ltd.
Hyderabad
07.2020 - 07.2021
  • Directed QC and compliance strategy for multiple formulation and API units.
  • Led a team of 200+ for audit readiness and regulatory compliance.
  • Implemented harmonized procedures and streamlined data integrity controls.
  • Facilitated external audits and customer inspections.

General Manager – Quality / Compliance

Syngene International Ltd.
Bangalore
06.2016 - 01.2020
  • Oversaw QA and QC functions for CDMO projects across small molecules and biologics.
  • Led regulatory and client inspections (USFDA, EMA, WHO), ensuring audit readiness and risk mitigation.
  • Implemented phase-appropriate quality systems for early-phase and commercial manufacturing.
  • Directed quality governance for tech transfers and analytical method validations.
  • Led data integrity, audit trail review, and electronic system validation initiatives aligned with GAMP 5 and 21 CFR Part 11.
  • Fostered quality culture through cross-functional training and compliance engagement programs.

General Manager – Corporate Quality Control

Hetero Drugs Ltd.
Hyderabad
08.2014 - 05.2016
  • Developed and standardized quality systems across group QC labs.
  • Spearheaded implementation of LIMS and electronic audit trail reviews.
  • Conducted corporate internal audits and regulatory preparedness reviews.
  • Collaborated with RA for global regulatory submissions and responses.

Head – Quality Control

Cipla Ltd. and Hetero Labs Ltd.
01.2000 - 01.2014
  • Oversaw the compliance of QC activities for high-potent oncology and sterile products.
  • Implemented validated software solutions and drove compliance with ISO 9001/27001 standards.
  • Led quality risk analysis, stability programs, and cross-site audit preparedness.
  • Supported RA teams on global filings and regulatory responses.
  • Developed internal audit frameworks and training protocols.

Education

M.Sc. - Chemistry

Acharya Nagarjuna University
Andhra Pradesh

B.Sc. - Physics, Chemistry & Mathematics

Calicut University
Kerala

Skills

  • Global compliance strategy
  • Regulatory audit management
  • Risk assessment and mitigation
  • Compliance training and culture
  • Data integrity and audit review
  • Computer system validation
  • CAPA and change control
  • LIMS implementation and governance
  • Cross-functional leadership
  • Customer audit readiness

Certification

  • Six Sigma Champions Training – IACET
  • LabWare LIMS Administration
  • Data Integrity Symposium – USFDA
  • CPhI Worldwide (Paris)
  • Agile Methodologies & CSV Principles for Life Sciences

Languages

  • English
  • Hindi
  • Malayalam
  • Tamil
  • Kannada
  • Telugu
  • Arabic

Compliance Standards

  • ISO 9001
  • ISO 27001
  • GAMP5
  • 21 CFR Part 11
  • Annex 11
  • ICH Q8–Q10

Application

Application for Senior Leadership Role in Pharmaceutical Quality & Compliance, [Date]

Timeline

Sr. Quality Consultant

The Quantic Group
02.2025 - Current

Vice President – Quality (Cluster Head)

Aurobindo Pharma – Apitoria Division
07.2021 - 11.2024

Senior General Manager – Head, Quality Control

Hetero Drugs Ltd.
07.2020 - 07.2021

General Manager – Quality / Compliance

Syngene International Ltd.
06.2016 - 01.2020

General Manager – Corporate Quality Control

Hetero Drugs Ltd.
08.2014 - 05.2016

Head – Quality Control

Cipla Ltd. and Hetero Labs Ltd.
01.2000 - 01.2014

M.Sc. - Chemistry

Acharya Nagarjuna University

B.Sc. - Physics, Chemistry & Mathematics

Calicut University

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