Computer System Validation Specialist

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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:

• 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.
• Requires a thorough knowledge and understanding of computer system validation processes and regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11and other harmonized international guidelines (PIC/S, ICH) and GxP.
• 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).
• Hands-on experience in validation of GxP systems is required.
• Experience in auditing of IT and validated systems are 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 work load and consistently meet deadlines
• Practical understanding of project management principles and methodologies.
• Experience in creation and review of Standard Operating Procedures (SOP’s) is desirable.
• Experience in using automated enterprise testing tools is an asset in order to support and assist company’s testing initiatives.
• Experience with one of the following testing tools is an asset: Quality Center, LOADRUNNER, or QUICKTEST PRO.
• Working knowledge of relevant technology, tools and software; knowledge of UNIX, SDLC, Desktop services, HP Test tools, or equivalent testing tools.

We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.

Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.

AmerisourceBergen is 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.

As of October 18, 2021, AmerisourceBergen requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation. 

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.