Job Details

Primary Duties & Responsibilities:

Support the computer system validation process by ensuring alignment of operations with system requirements, corporate policies, industry standards, and applicable regulation. Lead in the gathering of business requirements and system integration design, identifying gaps in software, conducting effective risk assessments, evaluating mitigation strategies, execution of validation testing, defect resolution and completion of validation deliverables. Prepare Electronic Document Management Systems and any configuration management tools. Prepare, execute, and analyze Validation Protocols such as validation plan (VP), BRD, IQ/OQ/PQ protocols, Requirement Traceability Matrix (RTM), Release Memo, and Validation Summary Reports (VSR); Interact with cross functional teams comprised of project managers, business and portfolio owners and business operations. Utilize systems compliance with FDA 21 CFR part 11 and cGxP; Write queries in SQL, SQL database, or Microsoft relational databases to verify data in the pharmaceutical healthcare industry. Test documentation and management systems for HP Quality center with Team Foundation Server (TFS). Generate and revise Validation Master Plans (VMPs), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessment (RA), Final Summary Reports (VSR), and Change Control by providing instructions and scientific rationale for the performance of validation studies. Perform post-execution review of test case for completeness, accuracy and adherence to policies and procedures. Provide technical decision-making regarding validation strategies for complex projects. Maintain accountability for training validation test team on validation methods. #LI-DNI

Qualifications:

Requires a Bachelor's degree (or foreign equivalent) in Computer Science, Engineering (any) or a related discipline, plus five years of experience with: (1) Electronic Document Management Systems; (ii) prepare, execute, and analyze Validation Protocols including validation plan, BRD, IQ/OQ/PQ protocols, Requirement Traceability Matrix, Release Memo, and Validation Summary Reports. (Employer will also accept a Master's degree in the same fields and three years of experience) Experience must include: experience in the pharmaceutical healthcare industry utilizing systems compliance with FDA 21 CFR part 11 and GxP (GCP and GDP); writing queries in Microsoft relational databases to verify data, utilizing KeatGX for test documentation and executions tracking and reporting defects. Fully remote work available.

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. For details, visit https://www.virtualfairhub.com/cencora

Full time

Affiliated Companies
Affiliated Companies: AmerisourceBergen Services Corporation