Project Qualification Engineer
Project Qualification Engineer
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Job Description
Strategic planning for qualification aiming to complete as per customer promised timelines.
Lead and assist with Factory and Site acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting.
Perform detailed Root cause analysis for customer complaints pertaining to Qualification.
Participate in development of Qualification team GEMBA meetings sprints and log progress through completion
Ability to takearound a BIO Process equipment with customers during Factory Acceptance test
Oversee the perfection of Qualification protocols.
Profile require travel 6070 both Domestic and globally
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 suppliers 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 nonconformances
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 years experience in a quality and assurance development ideally within the biomedical or pharmaceutical industry
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
Wellorganized 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 inand 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 realworld 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/careers
Employment Type
Full-Time
