SARLIN NITA KANES
Klang
Summary
Detail-oriented Quality Assurance professional with a strong focus on regulatory adherence and process optimisation. Conducts thorough risk assessments and champions compliance initiatives to safeguard product integrity. Fosters collaborative relationships with suppliers and regulatory bodies to enhance quality assurance efforts.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Quality Assurance Specialist, Regulatory Affairs
Wellesta Healthcare Sdn Bhd (Remote)
04.2025 - Current
- Prepare and submit regulatory filings, pharmaceutical applications to NPRA.
- Planned, coordinated, and led internal and external audits, assessing compliance with GDP, GDPMD, ISO 13485, and other relevant regulatory requirements.
- Conduct follow-up activities after audits, including tracking corrective actions and ensuring timely resolution of any audit findings.
- Collaborated with external stakeholders, including suppliers and regulatory bodies, ensuring compliance of all products with regulatory and quality standards.
- Develop, implement, and maintain the company's QMS to ensure compliance with GDP and GDPMD.
- Monitored QMS performance, recommending continuous improvements to enhance process efficiency and effectiveness.
- Review and revise SOPs regularly to ensure they reflect current company policies and regulatory changes.
- Monitor and maintain product quality compliance in accordance with local regulations, such as local health authorities (NPRA, MDA, etc.).
- Proactively assess risks in distribution processes, supply chains, and product handling to maintain high-quality standards.
Senior Validation Engineer, Quality Assurance
Vital Healthcare Sdn Bhd
05.2024 - 03.2025
- Responsibilities include developing and executing validation protocols, assessing cleaning procedures, analyzing data, and documenting compliance with industry regulations.
- Developed and executed validation protocols for computerized systems, ensuring compliance with FDA and ISPE guidelines.
- Execute Performance Qualification (PQ) activities.
- Generate validation documentation, validations plans, and traceability matrices.
- Conduct risk assessment for system changes and upgrades.
- Contributed to ISO 13485, ISO 9001:2015 QMS, ISO 15378 TUV SUV, GDP, and NPRA audits, supporting regulatory compliance and quality assurance.
- A cleaning validation professional ensures that cleaning processes in manufacturing meet regulatory and quality standards.
- Managed budgeting processes for operational and capital expenditures, ensuring alignment with departmental objectives.
Executive Validation, Quality Assurance
Duopharma Biotech
07.2017 - 04.2024
Education
Bachelor of Science - Biomedical Science
Management & Science University
Shah Alam, Selangor01-2017
Diploma In Medical Laboratory Technology - Medical Laboratory Technology
Pusat Teknologi & Pengurusan Lanjutan
Shah Alam, Selangor01-2014
Skills
- Regulatory compliance
- Quality management
- ISO 9001 compliance
- Audit coordination
- SOP development
- Risk assessment
- OPEX & CAPEX budgeting
- SAP
- LabSolution
- Minitab
- Microsoft Office
- Analytical Skills
- Team leadership
- Stakeholder engagement
Certification
- Occupational First Aid with AED & CPR
- Internal Auditor Trained by SGS
- Basic GC Principle with Column selection; Ultra inert Flow Path Troubleshooting Guide by Agilent
- Pharmaceutical HPLC Analysis - APAC by Phenomenex
- Competency for Measurement Uncertainty by Trescal Institute
- Competency in Interpretation of Calibration Certificate
Accomplishments
- Equipment Transfer (Laboratory & Production), 2023-01-01
- Implemented SOPs and quality systems for startup company operations, 2024-01-01
Language
English
Bahasa Malaysia
References
Available upon request
Timeline
Senior Quality Assurance Specialist, Regulatory Affairs
Wellesta Healthcare Sdn Bhd (Remote)
04.2025 - Current
Senior Validation Engineer, Quality Assurance
Vital Healthcare Sdn Bhd
05.2024 - 03.2025
Executive Validation, Quality Assurance
Duopharma Biotech
07.2017 - 04.2024
Bachelor of Science - Biomedical Science
Management & Science University
Diploma In Medical Laboratory Technology - Medical Laboratory Technology
Pusat Teknologi & Pengurusan Lanjutan