Manage commissioning and qualification of BioPharma equipments. Lead and assist with Factory acceptance test and Site acceptance test, IQ/OQ including documentation review and reporting, Manage the completion of FAT and SAT and post tasks, Handling KPI, Root cause analysis pertaining to qualification. High matured handling with customers. Willing to travel both domestic and international- 70% travel profile
The Customer Quality Professional will be responsible for interpreting, building upon, and complying with company service standards. The holder of this position will carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions.
Main Responsibilities & Tasks:
Inspect or verify services are compliant with applicable requirements
Plan, organize and conduct audits/assessments of supplier's systems, processes and products
Work with services to close out any audit findings
Document and report audit/assessment results
Facilitate quality issues in conjunction with key stakeholders, resolving day to day problems
Perform effective containment and problem resolution for all non-conformances
Report and assess status of service performance
Provide education and coaching on quality systems, regulatory compliance issues and company initiatives
Provide support for product development
Qualification & Skills:
Bachelor degree in a relevant science, engineering or related subject
Minimum 5-8 years' experience in a quality and assurance development ideally within the biomedical or pharmaceutical industry with the ETO project background.
Professional Certification — In depth knowledge of Quality auditing, and regulatory standards
Good Technical Engineering knowledge, including ability to understand engineering drawing and standards
Ability to develop realistic work plans, set personal goals that align with company goals
Well-organized and methodical, with a superb attention to detail
Ability to prioritize and manage daily assignments
Excellent written and verbal communications skills to represent the company professionally
Establish and maintain positive working relationships with all in and external interfaces
Fluent in English
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers
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