Wipro
Location
Kolkatta | India
Job description
Job Description
Wipro Kolkata is inviting applicant of candidate having knowledge of CAPA in Medical devices The ability to conduct thorough investigations of non-conformances utilizing problem solving tools, data, interviewing subject matter experts, and driving a cross-functional team to determine root cause and corrective actions. Thorough understanding on ISO 13485, US FDA Need to have the ability to drive and document an investigation to determine root cause. Be able to understand where the process broke down, develop corrective action/preventive action plans and effectiveness verification. CAPA writing experience preferred, Technical Writing skills, Project Management, Post Market Surveillance and or Field Service background would be helpful. Should able to manage a CAPA from start to finish. From problem statement, root cause, developing corrective and or preventive action plans and effectiveness verification. Owning the investigation from problem statement to closure that includes the investigation, containment, corrections, root cause determination, corrective actions, effectiveness checks and closure. Need solid project management skills to drive timely completions of investigations and implementations by cross-functional team. Need to be able to document investigations is a clear way that demonstrates that a thorough investigation was performed to support the root cause(s) identified. Ability to work cross-functionally Utilize Trackwise to document the investigations, assign child task records Ability to present updates/status updates to executive leadership and to clearly articulate help needed to continue to drive the CAPA investigation to closure timely. Support and present CAPA during internal and external audits successfully. Desired Candidate Profile Graduate in any stream Experience - 3 yrs to 6 yrs Should have Knowledge in CAPA,7QC, 8D ,Trackwise,5WHY Ready to relocate to Kolkata Should be flexible in shifts Only Immediate joiners are requested to applyJob tags
Salary
