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Computer System Validation Specialist

2 months ago

Oakville, Ontario, Canada CB Canada Full time
Computer System Validation Specialist

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 on computerized systems, including hardware and software, to support business systems with GxP impact.
  • 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 and the completion of assigned projects within agreed deadlines.
  • Design and execute test cases, including functional tests, integration tests, and regression tests.
  • Provide guidance and support to other members of the validation team, including operational business units, IT, and 3rd-party vendors.
Requirements:
  • 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 a related field.
  • Thorough knowledge and understanding 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.
What We Offer:

AmerisourceBergen offers a competitive total rewards compensation package, including benefit programs that are comprehensive, diverse, and designed to meet the various needs across our associate population.

We are committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.