Project Qualification Engineer
Project Qualification Engineer
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Project Qualification Engineer
Job Location: Bengaluru Karnataka India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Work with operations personnel on quality and safety issues
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
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.
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 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 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
- 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
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.
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Employment Type
Full Time
Key Skills
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