Essential Functions:
Acts as validation coordinator for systems and application releases and project manager for validation activities. Assists management with maintaining project schedules and providing estimated levels of effort for validation tasks.
Serves as validation support for new releases and modifications to applications, throughout the software development life-cycle. Prepares validation plans, test cases, and validation summary reports, and executes test cases. Reviews and approves all change controls associated with the validated systems and PQ and change control documentation per SOP.
Ensures test scripts challenge the functional requirements and adequately demonstrate that the application meets the expectations of the business customer. Executes test scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably. Creates, updates, and manages sufficient data within the testing environment to accurately test software functionality. Addresses any PQ related issues arising from client or internal audits.
Cross-trains and mentors team members on systems expertise. May supervise the daily activities of junior team members, assigning, monitoring, and reviewing progress and accuracy of the work, directing efforts, and providing technical guidance on more complex issues.
Leads departmental and corporate process initiatives. Seeks to identify and pursue team process and validation improvement opportunities. Participates in the review and analysis of validation tools, systems, and processes.
Remains familiar with relevant contractual obligations, sponsor expectations, applicable regulations, and SOPs/WPDs. Advises business on regulatory trends.
Ensures that systems and their regulated applications remain in a validated state. Performs risk assessments on new systems. Communicates with IT, project sponsors, and support teams to maintain validation environment, access, and database content during projects.
Prepares for and represents departments within relevant system-related client/audit forums. Represents department in sponsor audits. Participates in or conducts vendor audits as appropriate for tools or systems in use.
Knowledge, Skills and Abilities:
Should have over all min of 8+ Years of expr in over all with min 5+ years of expr into manual testing.
Expert consultative and interpersonal skills with effective client-focused approach and excellent oral and written communication skills demonstrated through effective project leadership, customer relationship management, and training and mentoring of team members.
Proven attention to detail and problem-solving skills.
Demonstrated skills with Microsoft Office Suite (Word, Excel, PowerPoint, and Project). Proven ability to quickly learn new computer software with minimum of instruction and ability to employ validation script development software.
Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others.
Proven organization and time management skills with the ability to adapt and adjust to changing priorities and manage multiple projects with challenging/conflicting deadlines.
Thorough understanding of clinical trials operational processes and terminology and in-depth understanding of the software development life cycle (SDLC).
Sophisticated ability to identify and resolve technical problems in a professional environment, to include proven troubleshooting skills and ability to analyze software defects, assess the cause of test failures, and effectively explain how errors are produced.
Effective ability to attain, maintain, and apply comprehensive knowledge of GCPs, applicable SOPs/WPDs, and process maps. Proven ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans.
Excellent project management skills, including through the development, negotiation, and maintenance of sophisticated project schedules and timelines in accordance to project demands on a multi-disciplinary team.
Comprehensive knowledge of computer systems validation, applicable regulations, and system testing processes. Proven ability to realize validation process needs and provide solutions tailored to the application or system.
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