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About Johnson & Johnson Medical (Suzhou) Ltd.
Johnson & Johnson Medical (Suzhou) Ltd. is a renowned organization in the healthcare industry dedicated to improving the quality of life for people around the world. We are currently seeking a Senior Specialist in CAPA Management to join our team in Mumbai, Maharashtra, India.
Function: Customer/Commercial Quality, Quality
Category: Senior Analyst, Customer/Commercial Quality (P6)
Location: Mumbai, Maharashtra, India
Requisition Number: 2506233903W
Job Responsibilities of a Senior Specialist CAPA Management:
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- Facilitate the initiation of investigations and CAPAs, and monitor progress and approvals.
- Collaborate with key stakeholders, senior management, and governance bodies for awareness and resolution, as needed, including any issues impacting the progress toward completion of investigations, root cause analysis, impact analysis, and closure of CAPA Records, and to support the end-to-end NC/CAPA process.
- Ensure that CAPA procedures and requirements are followed and met.
- Monitor effectiveness of CAPAs to ensure the Root Cause is eliminated or reduced to acceptable level.
Qualifications for Senior Specialist CAPA Management :
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- Bachelor’s Degree in Life Science or related discipline or equivalent is required.
- At least 3 years of experience in an applicable compliance field and or equivalent experience/training in a related R&D area.
- Experience with Non-Conformance/CAPA management. Analytical and data skills. Excellent communication and writing skills demonstrated by the ability to develop clear and concise professional correspondence.
- Must be a problem solver, strategic thinker, and collaborator. Excellent organization, prioritization, and time management skills, adaptability, attention to detail, and ability to build and maintain relationships and partnerships across the organization.
- Ability to build and maintain cross-functional interactions and coordination. Ability to build consensus, influence, and negotiate.
- Knowledge in R&D related activities which may include safety related areas, safety reporting for both investigational and marketed products, clinical study coordination, etc. Knowledge of Quality Management, Project Management and/or Process Excellence concepts and practices.
