Computer System Validation (CSV) Specialist

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

PRIMARY DUTIES AND RESPONSIBILITIES :

• Implement Innomar’s computer system validation (CSV) strategy and lead validation efforts on computerized systems (hardware & software) to support business systems that have GxP impact, ensuring compliance with PIC / S Annex 11 and US-21CFR part 11 requirements is established and maintained at all times.
• Review and / or assist in developing validation strategies and associated documentation against the requirements of Innomar’s CSV Policy and Procedures, as well as the Validation Master Plan (VMP) to ensure that compliance and business needs are achieved.
• Prepare validation documentation packages, including development and execution of documentation for validation and qualification activities to support various computer system validation projects. Documents to be authored may include : Validation Plan, Requirements Trace Matrix, Risk Assessment, IQ / OQ / PQ Testing Protocols, Test Cases, Validation Summary Report, Change control, SOPs, etc.
• Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
• Effectively manage all assigned computer validation projects, enhancements, and requests for change (RFCs), including the review of high level estimates (HLEs) from IT / PM to ensure QA timelines provided / forecasted are consistent with the expected project completion date. Complete assigned projects and tasks within agreed deadlines.
• Design / create and execute test cases (e.g., functional tests, integration tests, challenge tests, regression tests, etc.) and setup data for tests scripts that are appropriate to the risks and purpose of the applications and enhancements.
• Provide guidance and / or support to other members of the validation team (including operational business units, IT and 3rd party vendors) in the development of validation deliverables, such as User Requirements Specifications (URS), 21CFR11 / Annex 11 assessments, Functional Requirements Specification (FRS), Design Specifications, etc.
• As necessary and where applicable for validated systems, obtain and review Unit Test documentation from the IT development team / vendor to ensure the codes released to the test environment have been adequately unit-tested prior to QA validation activities.
• Management of defects / deviations / incidents in validation projects, including :
• Logging all defects / deviations / incidents identified during IQ, OQ & PQ.
• Organizing defect / deviation / incident Triage Meetings with the required stakeholders to identify resolution – e.g., whether to fix and retest, or defer to a later release.
• Maintain and update defect / deviation / incident log with appropriate status prior to closure of the project for filing.
• Coordinate and manage validation and qualification testing documentation review, approval signoff, execution, and post-execution review.
• Maintain computer system validation documentation and archiving ensuring effective document retrieval when required.
• Coordinate with IT, QA and applicable business units in the training of validation project team members on testing and validation policies, practices and tools. This may include formal preparation of training materials, one-on-one training, and classroom training.
• Provide quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements.
• Conduct QA audits of IT and validation processes as scheduled.
• Review & provide input, where required, to CSV-related Standard Operation Procedures (SOPs) and / or policies, and ensure adherence to internal SOP’s and regulatory requirements.
• Keep current with relevant industry and regulatory guidelines.
• Coordinate and provide direct oversight of third party vendors / partners for all software validation activities assigned.
• Flexibility to work overtime when required.
• Comply with all appropriate policies, procedures and safety rules and regulations.
• Travel up to 10% of the time.
• Perform other related duties as assigned by QA management.

EXPERIENCE AND EDUCATIONAL REQUIREMENTS :

Requires a minimum of three (3) years hands-on experience in validation of GxP computerized systems and software development methodologies, preferably in the pharmaceutical, biotech or medical device environment with extensive experience in a matrixed environment and interactions with external vendors. A college or university degree in computer sciences (e.g. IT, information security, engineering, software programming, etc.) is required.

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS :

What Cencora offers

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

Full time