Philips QMS Software Validation Engineer 

South Africa, Free State, Dihlabeng Local Municipality 

69700770

QMS Software Validation Engineer

Your role:

• Assist project teams in creating validation documents including participating in developing application requirements and risk assessments.
• Review requirements and design specifications for compliance to established validation processes and procedures, and for suitability as input for test protocols.
• Create a traceability from requirement to test and identify the gaps in test coverage.
• Support the project team during test execution to ensure compliance and assist in documenting deviations.
• Act as independent observer during test execution to ensure GDP compliance and timely investigation and resolution of deviations; act as independent reviewer on test executions.
• Executes and /or manages SW validation & control activities.
• Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW application, which automate Quality System processes.
• Authors, reviews and/or approves SW validation deliverables for non- product SW, including but not limited to SW validation plans, requirement testplans/protocols/results,risk assessments, traceability matrix and summary reports.
• Applies specialized and multi-functional skills developed through job-related training and considerable on-the-job experience.
• Applies company policies and procedures to resolve a variety of issues.
• Frequently interacts with functional peer groups, demonstrating the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
• Proficiency in a validation methodologies and has understanding of related validation processes.
• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Ensures adherence to standards, procedures, guidelines and drives process improvements.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Identifies problems in specific validations and proposes solutions.
• Adaptive thinking in variable situations in order to analyze and interpret information
• Works autonomously within established procedures and practices.
• Normally receives general instructions on routine work, detailed instructions on new projects or assignments.
• Accountable for validation deliverables for program level.

You're the right fit if:

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

• Bachelor’s degree or diploma in technical/scientific discipline.
• 5+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
• 5+ years of experience with IT software applications development and using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
• Expertise in validation of enterprise-wide quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
• Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485/EU MDR and EU Annex 11.
• Ability to travel up to 25%

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.