NC CAPA LEAD QMS
Date de publication :
04 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Sao Jose dos Campos
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
We are searching for the best talent for NC CAPA LEAD QMS to be in Sao Jose dos Campos, Brazil
Purpose:
The NC CAPA Lead, QMS – Technology Quality manages Technology Quality (TQ) staff and contractors performing activities for improving or establishing oversight for all IT Shared Services Non-conformance and CAPA investigations. This individual will provide compliance support and quality leadership to TS Operations, Engineering, and Q&C in the investigation, resolution and documentation of individual quality problems and trends. This position will report to the CAPA Leader and will also be responsible for monitoring the incident and problem management processes (Service Reliability) to identify events or trends that may require Non-conformance and CAPA investigations.
You will be responsible for:
- Day-to-day execution of Technology Quality (TQ) Nonconformance (NC) and Corrective Action and Preventative Action (CAPA) investigations
- Provide compliance support and quality input to TS Operations, Engineering, and Q&C in the investigation, resolution and documentation of individual quality problems and trends
- Provides input for process improvement efforts through feedback to other TQ pillar functions
- Partners with JJTS organization to support the identification of quality issues within incident & reliability tickets
- Performs detailed assessments and trending of P1- P4 incidents (based on defined intervals) to identify individual quality concerns and any potential trends affecting GxP applications and infrastructure
- Creates NC Investigations and CAPA reports
- Provides feedback on compliance risks in Technology Services processes and procedures
- Provides input on the process procedures that meet operational, regulatory, and company policies
- Creates and modifies Quality System documentation inclusive of SOPs, WIs, Standards, and Guidelines
- Supports Inspection Readiness for the IT Incident/Problem/Reliability/NC/CAPA
- Communicates key messages and presentations to various cross-functional groups to gain support
- Identifies potential gaps with in-scope systems and processes, raises appropriate Non-Conformance, CAPA and drives remediation with business and IT alignment