Microsoft CopilotKneat PVPqTestJIRAHP ALMISPE GAMP 5
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The Computer System Validation (CSV) Specialist is responsible for implementing Innomar’s CSV strategy and leading validation activities for computerized systems, including hardware and software, that support GxP-impacting business processes. This role ensures ongoing compliance with PIC/S Annex 11 and 21 CFR Part 11 requirements. Responsibilities include prioritizing, executing, maintaining, and coordinating CSV activities; evaluating software applications against design specifications and user requirements; and serving as a liaison between IT, operational business units, QA, and external partners, where applicable. The CSV Specialist also supports software and application testing and ensures project expectations are clearly defined and met in accordance with company policies and procedures. This position reports to the QA Testing & Validation Team Lead or Manager.
PRIMARY DUTIES AND RESPONSIBILITIES
Implement Innomar’s CSV strategy and lead validation efforts for GxP-impacting computerized systems, ensuring compliance with PIC/S Annex 11 and 21 CFR Part 11 requirements is established and maintained.
Review and/or develop validation strategies and associated documentation in alignment with Innomar’s CSV Policy, CSV procedures, and Validation Master Plan to support compliance and business objectives.
Prepare validation documentation packages for CSV projects, including Validation Plans, Requirements Traceability Matrices, Risk Assessments, IQ/OQ/PQ protocols, test cases, Validation Summary Reports, change controls, and SOPs.
Evaluate changes in validated computerized systems using a risk-based approach and assign appropriate levels of validation requirements.
Design, create, execute, and review risk-based test cases, including functional, integration, challenge, regression, and other applicable tests, and prepare test data to support validation activities.
Provide guidance and support to validation team members, operational business units, IT, and third-party vendors in developing validation deliverables, including User Requirements Specifications, Part 11/Annex 11 assessments, Functional Requirements Specifications, and design specifications.
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Obtain and review unit test documentation from IT development teams or vendors, where applicable, to confirm code released to the test environment has been adequately unit-tested prior to QA validation activities.
Manage defects, deviations, and incidents identified during validation projects, including: Log deviations and incidents identified during IQ, OQ, and PQ activities. Organize defect, deviation, and incident triage meetings with required stakeholders to determine resolution plans. Maintain and update defect, deviation, and incident logs with appropriate status through project closure and filing.
Log deviations and incidents identified during IQ, OQ, and PQ activities.
Organize defect, deviation, and incident triage meetings with required stakeholders to determine resolution plans.
Maintain and update defect, deviation, and incident logs with appropriate status through project closure and filing.
Coordinate validation and qualification documentation review, approval, execution, and post-execution review activities.
Maintain and archive CSV documentation to support effective retrieval when required.
Coordinate with IT, QA, and applicable business units to train validation project team members on testing and validation policies, practices, and tools, including formal training materials, one-on-one coaching, and classroom training where needed.
Provide quality guidance and assessments to ensure validated systems are maintained and changed in accordance with current corporate and regulatory requirements.
Conduct QA audits of IT and validation processes as scheduled.
Review and provide input to CSV-related Standard Operating Procedures and policies, where required, and ensure adherence to internal SOPs and applicable regulatory requirements.
Keep current with relevant industry and regulatory guidelines.
Comply with all appropriate policies, procedures and safety rules and regulations.
This job profile description is a standardized, non-contractual reference description and global reference tool provided for organizational consistency and talent architecture purposes across Cencora. It does not alter actual job duties, responsibilities, reporting lines, working conditions, grading, compensation, or other essential terms and conditions of employment. Actual duties and responsibilities may vary based on business needs, local requirements, and operational practices. Where a team member's role is governed by an employment agreement, local terms and conditions, prior job description or collective bargaining agreement, those documents shall prevail in case of any inconsistency. Mandatory local laws shall also prevail.
EXPERIENCE AND EDUCATIONAL REQUIREMENTS
Requires a minimum of three (3) years of hands-on experience validating GxP computerized systems and working with software development methodologies, preferably in the pharmaceutical, biotechnology, or medical device industry. Experience in a matrixed environment and collaborating with external vendors is preferred. A college or university degree in computer science, information technology, information security, engineering, software programming, or a related discipline is required.
MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS
Requires formal training in the field of computer sciences (e.g. IT, information security, engineering, software programming, etc.), business administration or similar vocations generally obtained through completion of a four-year Bachelor’s Degree program, technical vocational training, or equivalent combination of experience and education.
Thorough knowledge and understanding of CSV processes and regulatory requirements, including ISPE GAMP 5, 21 CFR Part 11, Annex 11, PIC/S, ICH, and GxP guidelines.
Ability to communicate effectively both orally and in writing is a must.
Demonstrated understanding of quality assurance and quality systems principles (training documentation, change control, validation, vendor management and audits).
Experience auditing IT processes and validated computerized systems is required.
Excellent teamwork and interpersonal skills; leadership and relationship building skills.
Strong analytical, problem-solving, and conceptual skills.
Excellent organizational skills; attention to detail.
Ability to resolve system issues effectively and efficiently.
Ability to prioritize workload and consistently meet deadlines.
Practical understanding of project management principles and methodologies.
Experience in creation and review of Standard Operating Procedures (SOP) is desirable.
Experience in using automated enterprise testing tools is an asset to support and assist company’s testing initiatives.
Experience with testing and validation tools such as Kneat PVP, qTest, JIRA, HP ALM, or equivalent platforms is an asset.
Working knowledge of relevant technologies, testing tools, automation platforms, Microsoft Copilot, or other AI-enabled tools is an asset.
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.
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Accessibility Policy
AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.
