Quality Assurance Specialist - Clinical

The role involves supporting and maintaining the Quality Management System (QMS), handling CAPA, deviations, non-conformances, change controls, SOPs, quality documentation, audits, and compliance activities, while ensuring adherence to applicable regulatory and quality standards. The candidate will also be responsible for quality investigations, documentation review, corrective and preventive actions, and continuous improvement of quality processes.

Qualifications

• Bachelor's degree in Pharmacy, Biotechnology, Life Sciences, Microbiology, or a related field.
• Candidate must have 2–3 years of relevant QA experience in a clinical, pharmaceutical, medical device, or healthcare environment.
• Hands-on experience with CAPA and deviation management.
• Knowledge of QMS, SOPs, non-conformances, change controls, and quality documentation.
• Experience in internal and external audits and audit preparation.
• Good understanding of applicable ISO and regulatory quality standards.
• Strong documentation, analytical, communication, and problem-solving skills.
• Good proficiency in MS Office, particularly Excel and Word.