Global CAPA Manager Job Agilent Technologies Inc Carpinteriaby admin on more than 30 days
Agilent Technologies, Inc. Job Vacancies 2020Description :
inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. enables customers to gain the answers and insights they seekso they can do what they do best: improve the world around us. Information about is available at www.agilent.com.
Primary responsibilities of the Global CAPA Manager include:
- Assume the important role of CAPA Process Owner and be the CAPA Champion across the organization.
- This position is required to assess and provide a clear vision of CAPA compliance across the business through driving strategy, direction, management, and oversight of the global CAPA program.
- Develop and maintain the CAPA policies and procedures.
- Responsible to ensure that the CAPA Policy and Procedure meet all applicable requirements and regulations, including but not limited to, Regulations for United States FDA 21 CFR Part 820, ISO 13485, IVDD and IVDR.
- Chair the CAPA boards and ensures that CAPAs managed meet all internal and external regulatory requirements.
- Identify and escalate any compliance issues and their potential impact across the business so that they can be effectively resolved. Report any lack of compliance and potential areas of compliance vulnerabilities.
- Provide supervision and training, as required for direct reports to manage CAPA. Support direct reports in gaining knowledge of all applicable standards, regulations, policies, procedures and work instructions, as per individual development plan.
- Conduct project work and team tasks as required.
- Provide strategic oversight to the CAPA programs at each site, helping to ensure site resources who manage CAPA have appropriate training and qualifications
- Responsible for developing CAPA training content and ensuring training is implemented
- Ensure global CAPA program health by providing metrics and reporting to business leaders
- Responsible for collection, production and publication of compliance data related to CAPA.
- Interface with all sites and site stakeholders for technical assistance and problem solving in areas of CAPA.
- Present to FDA, Notified Body, or senior executive leadership on the overall status and performance of the CAPA process.
- Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
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