Description

• Responsible for all aspects of Quality Assurance activities for compliance to company standards.
• Participation in the development and maintenance Corrective Action / Preventive Action, Non-Conformance Reports, Checklists, SOPs and Work Instructions.
• Perform Risk Analysis, Root Cause Analysis, and Failure Analysis.
• Provided gap assessments, problem statements, containment activities, root cause analysis, corrective action plans for several major findings within the company’s quality audit.
• Support the onsite Integration to Johnson & Johnson Standards, which include providing gap assessments, impact assessments, updating/obsoleting current onsite SOP’s and Work Instructions.
• Responsible for ensuring compliance with all the required procedures and establishing the inspection plan and methods for ensuring conformance to specifications. Responsible for revising standard procedures and protocols with revision summary.
• Coordinate the Offshore and onsite teams to ensure the Periodic Review of Documents is done per the site-specific procedure and timeline.
• Provide support to CAPA process. Identify CAPAs that require periodic review, including risk re-assessment.
• Compiled NCR’s appropriately when needed and identify the need to initiate CAPA.
• Identify and escalate trends or other input for CAPA consideration.
• Facilitate Documents for onsite audits.