Summary
Overview
Work History
Education
Skills
Certification
WEBSITES, PORTFOLIOS, PROFILES
Timeline
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Anwar Sulaiman K.C.

Anwar Sulaiman K.C.

Consultant Opportunity in Pharmaceutical Quality
Hyderabad

Summary

Accomplished Quality & Compliance Leader with 25+ years of expertise across APIs, OSDs, and injectables. Proven success in directing Pharmaceutical Quality Systems, managing regulatory inspections (US FDA, EMA, PMDA, WHO), driving Data Integrity initiatives, and leading global compliance programs. Recognized for building compliant, high-performing teams, and implementing digital quality systems (LIMS, QMS, audit trails) to ensure sustainable GMP compliance.

Overview

29
29
years of professional experience
7
7
Certifications
8
8
Languages

Work History

SENIOR QUALITY CONSULTANT

The Quantic Group
01.2025 - Current
  • Provide independent QA oversight for regulatory compliance, Remediations, QMS.
  • Lead data integrity assessments, Process Investigations, Quality Compliance.
  • Guide remediation of laboratory systems, microbiological investigations, and sterility OOS cases.
  • Conduct inspection readiness reviews aligned with US FDA, EMA Annex 1, and WHO standards.
  • Mentor teams to strengthen investigation quality, root cause analysis, and compliance culture.

VICE PRESIDENT – QUALITY (CLUSTER HEAD)

Aurobindo Pharma – Apitorla Division
07.2021 - 11.2024
  • Overall responsibility for production and laboratory quality assurance across API and formulation sites.

SR. GENERAL MANAGER – HEAD, QUALITY CONTROL

Hetero Drugs Ltd.
07.2020 - 07.2021
  • Directed QC activities for multiple API and formulation units.
  • Implemented harmonized laboratory SOPs and streamlined data integrity controls.
  • Led 200+ staff, ensuring audit readiness for FDA, EMA, and PMDA.
  • Conducted OOS/failure investigations and monitored CAPA effectiveness.

GENERAL MANAGER – QUALITY/COMPLIANCE

Syngene International Ltd.
06.2016 - 01.2020
  • Oversaw QA/QC for CDMO projects (small molecules & biologics).
  • Led client and regulatory inspections (FDA, EMA, WHO).
  • Directed quality governance for tech transfers and method validations.
  • Implemented electronic system validation aligned with GAMP5.
  • Promoted quality culture via cross-functional training.

GENERAL MANAGER – CORPORATE QUALITY

Hetero Drugs Ltd.
08.2014 - 05.2016
  • Standardized quality systems across group.
  • Established Corporate Quality setup and procedures.
  • Initiated periodic Quality Review Meetings with top management.
  • Successfully completed multiple audits by global trial sponsors.
  • Spearheaded LIMS implementation and audit trail governance.
  • Conducted corporate internal audits and global submission support.
  • [+ 08/2006-09/2011]

HEAD – QUALITY CONTROL

Cipla Ltd. & Hetero Labs Ltd.
01.2000 - 08.2006
  • Oversaw QC operations for oncology and sterile products.
  • Managed analytical method validation, stability programs, and risk analysis.
  • Directed audit preparedness and supported global regulatory filings.
  • [+ 09/2021 – 07/2014]

LABORATORY ASSISTANT – QC

Max Pharma
04.1996 - 03.2000
  • Conducted analysis, calibration, and laboratory compliance activities.

Education

M.Sc. - Chemistry

Acharya Nagarjuna University

B.Sc. - Physics, Chemistry & Mathematics

Calicut University

Ph.D. - Chemistry

Reva University

Skills

Pharmaceutical Quality Systems

Certification

Six Sigma Champions Training – IACET

WEBSITES, PORTFOLIOS, PROFILES

linkedin.com/in/anwar-sulaiman-29086120

Timeline

SENIOR QUALITY CONSULTANT

The Quantic Group
01.2025 - Current

VICE PRESIDENT – QUALITY (CLUSTER HEAD)

Aurobindo Pharma – Apitorla Division
07.2021 - 11.2024

SR. 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

Hetero Drugs Ltd.
08.2014 - 05.2016

HEAD – QUALITY CONTROL

Cipla Ltd. & Hetero Labs Ltd.
01.2000 - 08.2006

LABORATORY ASSISTANT – QC

Max Pharma
04.1996 - 03.2000

B.Sc. - Physics, Chemistry & Mathematics

Calicut University

M.Sc. - Chemistry

Acharya Nagarjuna University

Ph.D. - Chemistry

Reva University

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Anwar Sulaiman K.C.Consultant Opportunity in Pharmaceutical Quality