Description

Manage quality assurance processes and regulatory compliance for manufacturing and laboratory workflows.

This role is on-site.

Responsibilities

• Review and issue Certificates of Conformance via Device History Records (DHR).
• Apply Good Manufacturing Practices (GxP) and Good Laboratory Practice (GLP) standards to all workflows.
• Investigate technical issues to identify and resolve root causes.
• Collaborate with interdepartmental teams to manage quality tasks under pressure.
• Maintain accurate documentation and data within enterprise systems.

Required Skills

• Experience with SAP, Quality Tracking System (Trackwise), and LIMS.
• Proficiency in MS Office applications.
• Deep knowledge of current Good Manufacturing Practices (GxP) and regulations.
• Strong knowledge of Good Laboratory Practice (GLP).
• Ability to perform DHR reviews and Certificate of Conformance issuance.
• Bachelor’s degree with at least three years of experience, or an Associate's degree with six years, or eight years of relevant experience.
• Master’s degree with more than one year of experience.

Key Skills

Education

Any Graduate