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Project Qualification Engineer

5.00 to 8.00 Years   Bengaluru/ Bangalore (Karnataka)   21 Feb, 2025
SARTORIUS
Job LocationBengaluru/ Bangalore (Karnataka)
EducationAny Graduate
SalaryAs per Industry Standards
IndustryManufacturing/Industrial
Functional AreaProduction/Manufacturing/Maintenance/Packaging
EmploymentTypeFull-time

Job Description

  • 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 the development of Qualification team, GEMBA meetings, sprints, and log progress through completion.
  • Ability to take-around a BIO Process equipment with customers during Factory Acceptance test.
  • Oversee the perfection of Qualification protocols.
  • Profile requires travel 60-70 PERCENT 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 non-conformances.
  • Report and assess the 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 the 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 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 internal and external interfaces.
  • Fluent in English.
About SartoriusSartorius 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/careersLocations: Bangalore

Keyskills :
quality assurance root cause analysis regulatory compliance audit management technical engineering knowledgeamp safety product development process equipment documentation

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