Quality Assurance Executive

Role & responsibilities

• Experience of handling licensing authority.
• Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc).
• Managing Document Control system-Tracking Document changes, Create Quality.
• Manual, SOPs (Standard operating Procedure),maintain computerized and written records/reports.
• Responsible in implementing companys quality system in compliance with regulatory body.
• Ensure requirements of licensing authorities and accreditation bodies.
• GAP analysis , Risk assessment.
• Working as a management representative.
• Assure work process improvement and problem solving.
• Conduct Quality Training.
• Conduct/perform Internal Quality Assessment.
• Coordinate workplace safety process improvements and safety audits.
• Conduct Internal Audit ,prepare audit report ,initiate management review meeting.
• Initiate CAPA for the deviation.

Preferred candidate profile

• Experience in ISO.
• 25 years in quality or regulatory affairs in a healthcare segment.
• Must have Technical & Regulatory Knowledge.
• Quality & Compliance along with Technical skills.
• Communication, Critical Thinking, Organizational, Attention to Detail.