Job Description: Pay Range: $65hr - $70hr
- Regulatory process implementation Application Periodic reviews Customer and team management.
- Experience in QMS implementation.
- Hands on experience in Application Periodic Reviews , Risk ManagementGAMP5 guidelines GxP processes Supplier Assessments Training Management Metrics Management Configuration Management (CMDB Doc Control)Process implementation experience in SDLC environment.
- Good experience in external and internal regulatory audit management.
- Hands on experience in CAPA and Process Improvements.
Qualification:
- Minimum requirement is a bachelor s degree in computer science, Sciences or a related education (e.g. life science, medicine) , master's preferable.
- To be responsible for providing technical guidance to a team of developers, enhancing their technical capabilities and increasing productivity.
- To conduct comprehensive code reviews, establish and oversee quality assurance processes, performance optimization , implementation of best practices and coding standards to ensure successful delivery of complex projects.
- To ensure process compliance in the assigned module, and participate in technical discussions or review as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
- To collaborate with stakeholders to define project scope, objectives, deliverables and accordingly prepare and submit status reports for minimizing exposure and closure of escalations.