Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Roles & Responsibilities:
- Process qualification and non-conformance investigations and work independently with limited guidance.
- Provides team leadership to Supplier Quality through cross-functional collaboration with procurement, quality assurance, engineering, and with suppliers.
- Supports and sustains robust supplier management programs for designated manufacturing and development activities.
- Supports department projects and investigations relating to Supplier Quality issues.
- Review of deliverables and ensure quality and on-time delivery.
- Adhere project priorities, schedule, and present project status on weekly basis.
- Responsible to interact with cross-functional teams for protocols, reports, and relevant documents sign-off
- Follow clean room procedures and good documentation practices
- Responsible for project status reports, participating meetings and suggest improvements.
- Experience in creation of Forms, Checklists, Work Instruction, Standards, SOP's etc.
- Excellent knowledge of Medical Standards ISO 13485, ISO 14971 & 21 CFR part 820.