Summary
Overview
Work History
Education
Skills
Language Proficiencies
Professional Development
Timeline
Generic
Ai See Lim-Bröchin

Ai See Lim-Bröchin

Dornach

Summary

Accomplished senior executive with over 22 years of extensive experience in quality systems, regulatory compliance, qualification and validation for international companies. A strategic problem solver and adept quality assurance leader, skilled in directing teams of professionals. Renowned as a QA technical expert for audits, regulatory inspections, GxP training, qualification, validation, CMC dossiers, and regulatory compliance. Proven track record in delivering quality assurance leadership and ensuring rigorous compliance with industry standards.

Overview

16
16
years of professional experience

Work History

Head of QA Compliance

ACINO PHARMACEUTICAL AG
01.2020 - Current
  • Leading team of 14 QA Managers across regional sites
  • Successfully hosted health authority inspections by Swissmedic, PMDA, Russian, Libya and customers audit with zero critical observations
  • Quality owner of all internal quality and system compliance, self-inspections, customer audits, health authority inspections, CMC dossiers submission, regulatory compliance, regulatory and engineering change controls, GxP trainings, annual product quality, Trends review, deviation, compliance and quality risk assessments, qualification and validation activities
  • Acted as Subject Matter Expert for all aspects of quality and resolved issues related to regulatory compliance to assure products supply reliability
  • Maintained customers relations and external communication with third parties

Senior, QA Validation Specialist

NOVARTIS TECHNICAL OPERATION
01.2016 - 08.2019
  • Supervising QA activities in system qualification, sterilization hold studies, process validation, cleaning validation, and environmental monitoring in clean rooms
  • Supporting site-wide discrepancies, deviations, leading deviation investigations, CAPA, and effectiveness reviews to ensure adherence to company procedures and quality standards
  • Serving as Agile PLM asset change control QA gate approver, evaluating quality-related changes and final impact assessments
  • Independently implementing dynamic site-wide validation program updates and developing required training strategies for site personnel
  • Approving site-wide validation protocols, plans, and standard operating procedures

Manager, Compliance Audit Group

GLAXO SMITH KLINE (GSK) SINGAPORE
04.2015 - 09.2015
  • Co-auditor in Good Manufacturing Practice compliance audits of local manufacturing sites
  • Established robust audit plan based on risk assessment strategies

Commissioning and Validation, Consultant / Lead

COMMISSIONING AGENTS INTERNATIONAL
03.2013 - 03.2015
  • Developed documents for cleaning validation, risk assessments, validation master plans, user requirement specifications, DQ, IQ, OQ, PQ, and PV protocols for process equipments, utilities, computer systems and clean room systems in accordance with ISPE baseline guides and ASTM E2500 principle
  • Consultant for customers such as Mead Johnson, Novartis, Roche, Impax, Abbott, Prime Biologics and Depuy Orthopaedics.
  • Developed robust data integrity policies that enhanced overall quality assurance measures

Validation & Compliance Manager

M+W GROUP (S) PTE. LTD
03.2008 - 12.2012
  • Leading regional team of 10 QA engineers, driving excellence in quality assurance practices.
  • Overseeing overall quality assurance, validation, and GMP compliance management to uphold industry standards.
  • Serving as a trusted GMP consultant for a government pharmaceutical facility in Thailand, providing strategic guidance on regulatory compliance and operational best practices.
  • Enhanced overall business operations by continuously improving policies, procedures, and controls related to compliance requirements.
  • Developed comprehensive training programs for employees, fostering a culture of compliance throughout the organization.
  • Managed compliance efforts, reporting and audits.

Education

Master of Science in Chemical Engineering (MSc.) -

National University of Singapore
SINGAPORE
06.2007

Bachelor of Science (BSc.) in Chemical Engineering -

University of Technology Malaysia
MALAYSIA
07.2001

Skills

  • Audit, Inspection & CAPA Management SME
  • Lead Deviation Investigation
  • Cleaning Verification/Validation
  • Regulatory Dossier Compliance
  • Training & Coaching of Employees
  • System & Equipment Qualification
  • Process Verification/Validation
  • Microbiological Control Strategy
  • Standard Operating Procedures Review/Approval
  • Regulatory & Guideline Analysis
  • Quality Risk Assessments
  • Change Control
  • Senior Leadership Relationships
  • Project Management Leadership
  • Aseptic Fills Operation

Language Proficiencies

Chinese Native, English Fluent, German Level B1-B2

Professional Development

  • A Risk-Based Corrective Action and Preventive Action, ASQ, 2016
  • ISPE Conference, 2011 – 2014
  • Risk Management & Validation Training, AVT, 2011 – 2012
  • Core Management Leadership, 2012
  • GMP Audit Workshop, TGA Inspector, 2014

Timeline

Head of QA Compliance

ACINO PHARMACEUTICAL AG
01.2020 - Current

Senior, QA Validation Specialist

NOVARTIS TECHNICAL OPERATION
01.2016 - 08.2019

Manager, Compliance Audit Group

GLAXO SMITH KLINE (GSK) SINGAPORE
04.2015 - 09.2015

Commissioning and Validation, Consultant / Lead

COMMISSIONING AGENTS INTERNATIONAL
03.2013 - 03.2015

Validation & Compliance Manager

M+W GROUP (S) PTE. LTD
03.2008 - 12.2012

Master of Science in Chemical Engineering (MSc.) -

National University of Singapore

Bachelor of Science (BSc.) in Chemical Engineering -

University of Technology Malaysia

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Ai See Lim-Bröchin