Computer System Validation Specialist
4 hours ago
AmerisourceBergen is seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of computerized systems that support our business operations.
Key Responsibilities:- Develop and implement computer system validation strategies to ensure compliance with regulatory requirements.
- Lead validation efforts for computerized systems, including hardware and software, to ensure GxP impact is established and maintained.
- Review and develop validation documentation, including validation plans, requirements trace matrices, risk assessments, and test protocols.
- Manage validation projects, including the review of high-level estimates from IT/PM to ensure QA timelines are consistent with project completion dates.
- Design and execute test cases, including functional tests, integration tests, and regression tests, to ensure system validation.
- Provide guidance and support to other team members on validation deliverables, including user requirements specifications and 21CFR11/Annex 11 assessments.
- Minimum of three years of experience in validation of GxP computerized systems and software development methodologies.
- College or university degree in computer sciences, business administration, or similar field.
- Thorough knowledge of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11, and other harmonized international guidelines.
- Excellent communication and teamwork skills, with the ability to lead and collaborate with cross-functional teams.
AmerisourceBergen offers a competitive total rewards compensation package, including benefit programs that are comprehensive, diverse, and designed to meet the various needs of our associates. We take a balanced approach to benefits, with many programs available through company-paid contributions and others available through associate contributions.
Our commitment to our associates includes a focus on work-life balance, professional development, and community involvement. We strive to create a positive and inclusive work environment that supports the well-being and success of our associates.
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Computer System Validation Specialist
2 days ago
Oakville, Ontario, Canada CB Canada Full timeComputer System Validation SpecialistAmerisourceBergen is seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of computerized systems that support our business operations.Key Responsibilities:Develop and implement computer system...
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Computer System Validation Specialist
2 days ago
Oakville, Ontario, Canada CB Canada Full timeComputer System Validation SpecialistAmerisourceBergen is seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of computerized systems that support our business operations.Key Responsibilities:Develop and implement computer system...
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Computer System Validation Specialist
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Oakville, Ontario, Canada CB Canada Full timeComputer System Validation SpecialistAmerisourceBergen is seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of computerized systems that support our business operations.Key Responsibilities:Develop and implement computer system...
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Computer System Validation Specialist
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Oakville, Ontario, Canada CB Canada Full timeComputer System Validation SpecialistAmerisourceBergen is seeking a highly skilled Computer System Validation Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the validation of computerized systems that support our business operations.Key Responsibilities:Develop and implement computer system...
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