2 Opening(s)
3.0 Year(s) To 4.0 Year(s)
6.50 LPA TO 8.00 LPA
Role:
• Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.
• Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.
• Drafting and revising pre-clinical summaries.
• ...
1 Opening(s)
2.0 Year(s) To 4.0 Year(s)
4.00 LPA TO 6.00 LPA
Quality Assurance Specialist Responsibilities:
Ensure product quality and conformity to regulatory standards, including Medical Device Regulation (MDR) and Quality Management System (QMS).
Conduct internal quality audits and participate in management review meetings.
Handle investigations of complaints and implement corrective and preventive actions.
Maintain and update quality manuals, formats, and standard operating procedures (SOPs) in ...