QSR Specialist

• Supporting external audit processes and the internal audit activities.
• Supporting the compliance gap management activities including regulatory /standards tracking and other compliance management activities.

• Support assigned internal/clinical audits to maintain timely closure of the audit cycles. May lead the assigned audits.
• Support Audit Readiness activities for external audits including training staff /guidance in preparation of external audits
• Support compliance gap management activities e.g. compliance risk management- Identifies risks to the division and resolutions to address compliance gaps.
• Help management of near miss program
• Prepares the metrics data
• Promotes awareness and understanding of quality & compliance within the division.
• Provide training to the division to increase the compliance awareness
• Participate the compliance initiatives and other assigned projects

QUALIFICATIONS

• Bachelors Degree or an equivalent combination of education and work experience
• Minimum 3 years in Quality Assurance, Internal Auditing, Quality Compliance Management or related experience
• Minimum 5 years in Medical Device /Pharma