Validation Analyst Job in Rockville 20852, Maryland US

Work Location:

 Rockville, MD

Shifts:

 Not Applicable

Positions Available:

 2

Position Summary

Under the direction of the Validation Manager and in consultation with the computer system validation (CSV) vendor, the Validation Analyst supports the computer system validation process by ensuring alignment of operations with system requirements, corporate policies, industry standards, and applicable regulations. As a key member of the team, with expertise in SDLC, CSV, microsoft platforms, databases, reporting, testing and document management tools, this individual will utilize these skills to assist in providing the IS/IT and Quality team with technical expertise on software validation, project coordination, and change control activities for GAMP-5 Class V, in-house, custom designed systems . This individual will also lead in gathering business requirements, identifying gaps in the software, conducting effective risk assessments, evaluating mitigation strategies, execution of validation testing, defect resolution and completion of validation deliverables. The individual should be a good team player with excellent communication. motivation, team building and mentoring skills with the ability to work independently and in rapport with Business Analysts, Functional Leads, End-users, Quality and Project Managers.

Primary Duties and Responsibilities

- Assists in the development, planning, directing and tracking of the validation of computer systems supported by the IS/IT team.

-- Works with the project teams to develop validation strategies for projects and works closely with project managers and program managers to meet the deadlines.

- Leads the technical and business analysis team members to ensure compliance with system requirements, corporate quality standards, HIPAA guidelines and FDA regulations (21 CFR part 11 and/or 820).

- Maintains production computer systems in a regulatory compliant state, monitors all modifications or changes to systems or processes, initiates change control / revalidation as required and ensures a continual state of inspection readiness with regard to validation guidelines.

- Coordinates project activities which includes, but not limited to developing project plans, kick off presentations, sending communication plans, establishing risk mitigation strategies and identifying crucial success factors for the deployment of the project.

- Generates/revises Validation Master Plans (VMP), Qualification Protocols (IQ/OQ/PQ), Trace Matrices (RTM), Test Plans, Risk Assessments (RA), and Final Summary Reports (VSR) by providing instructions and scientific rationale for the performance of validation studies.

- Coordinates the testing efforts of the IS/IT and business teams with regards to requirements, resource planning, test coverage and test strategies.

- Works in parallel with the business SMEs and IS Applications staff to create thorough, accurate and comprehensive test scripts.

- Develops, maintains and executes validation test scripts, test metrics and generates reports for management use in determining project and applications test status and coordinates testing schedule with IS/IT team.

- Investigates, gathers and furnishes additional information about functional defects including log files, procedures to reproduce, etc., communicates concerns, and retains contact and continues discussion with the development staff as testing progresses to ensure test results are appropriate and meet client needs.

- Performs post-execution review of test cases for completeness, accuracy, and adherence to policies and procedures.

- Provides technical decision making regarding validation strategies for complex projects.

- Maintain accountability for training validation test team on validation methods.

- Oversees overall document management for all validation deliverables including, but not limited to:

-- Performs computer system regulatory compliance assessments for new programs per policies and procedures.

 

Experience and Education Requirements

BS or higher Degreee in Computer Science or equivalent experience.

5-7 years in related field, preferably healthcare. 3+ years experience applying regulations (FDA, 21 CFR Part 11 and/or 820, etc.); very strong software techinical aptitude, including experience with Microsoft platforms (such as ASP.NET, C#, VB Scripting), SQL, PL/SQL, SQL Server, Crystal reports, Oracle or other relational databases, Java scripting, Web and client server applications, SharePoint, MS-Project, Visio, test automation and test tracking tools, configuration management tools and electronic document management tools.

Minimum Skills, Knowledge and Ability Requirements

Expertise in all phases of Software Development Life Cycle (SDLC) and Computer System validation (CSV)

Working knowledge of FDA/cGXP; Strong working knowledge of Pharmaceutical (21 CFR 11 and/or 820) Regulations and software technical aptitude.

Ability to prepare, execute, and analyze validation studies and Validation Master Plans; Ability to communicate project status, issues, risks, plans, etc. within the organization.

Demonstrated experience working in a regulated environment requiring adherence to government or regulatory body policies and procedures.

Demonstrated knowledge of Quality Management Systems tools. The personnel should be able to lead software validation projects and change control efforts.

Able to respond/react with appropriate urgency/professionalism and make decisions under pressure. Supports goals and initiatives tied to the Quality Plan and departmental goals.

Ability to interface effectively with cross-functional teams resulting in overall regulatory compliance.

Additional Information


Job Code : HRReq009626
Division/Department : AmerisourceBergen Corporation