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Job Duties:

• Event Investigations and CAPA Efforts: You will be responsible for supporting the technical services team in their event investigations and CAPA efforts. This includes collaborating with team members to identify issues, conducting thorough RCA, assessing impacts, and developing CAPAs to rectify and prevent recurrence.
• Cell and Gene Therapy Manufacturing: Assist in the support of Cell and Gene therapy manufacturing processes. Work closely with manufacturing teams to ensure adherence to quality standards and regulatory requirements.
• Deviation and Investigation Management: Lead, write, and review deviations and investigations. Ensure that all deviations and investigations are conducted in accordance with established protocols and regulatory guidelines.
• Project Management: Manage multiple projects simultaneously, working with various stakeholders to ensure successful outcomes. Maintain a project management mindset to track progress, timelines, and resource allocation.
• Stakeholder Collaboration: Collaborate effectively with cross-functional teams, including quality assurance, regulatory affairs, and manufacturing, to drive process improvements and resolve technical issues.

Education: The minimum qualification required for the performance of the above occupation duties is a bachelor’s degree or equivalent in MIS, IT, Computer Science, Manufacturing or equivalent in a related field or a foreign equivalent is required closely related field with relevant experience.