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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