LifeScience Software Validation Analyst

Job Description:

This position supports the efforts associated with the IT application development team’s responsibility for Quality Assurance within Fisher BioServices. Responsible for managing validation efforts associated with the development and maintainence of in-house created and Commercial Off The Shelf (COTS) software. Support efforts to develop and update Quality Computer System Validation documentation for GxP compliance. Support development of the strategy, processes, and policies to create write, review, and/or approve validation protocols such as Validation Plan, IQs, OQs, and PQs, Standard Operating Procedures (SOPs), Summary Reports based on the Global Computer Validation Management policy and Global Quality Policy. Generate/manage deviations through TrackWise. Perform periodic reviews of validated software both in-house developed and COTS. Support the build-out and scale-up of new bio-banking, back office application, and related equipment containing software. Support all quality system activities leading to improved compliance with corporate policies, e.g. 21CFR Part 11, GxP, and other applicable regulatory agencies.

Key Responsibilities:
• Support the implementation of frameworks, methodologies and procedures for computer system validation.
• Manage the lifecycle of related documents such as procedures, instructions, change control, and validation documentation within IT to ensure proper and timely review, approval, execution and storage.
• Write and support the development of new and updated local Standard Operating Procedures (SOP) based on the Global Quality Computer System Validation Policy to assure compliance to GxP and 21 CFR; Part 11.
• Work with application development teams to develop test scripts and statistically sound tests for appropriate support of results.
• Author and/or perform timely and effective QA review of validation documentation such as SOPs, Master Validation Plans, Traceability Matrices, Testing deliverables, and Data Migration Plans.
• Lead validation support for IT change management documentation review. Ensure Quality & Compliance requirements are considered in any IT change initiative or GxP change request.
• Excellent understanding of 21 CFR Part 11, ICH standards, EMEA, GLP, GCP, GMP, GDP regulations, Sarbanes Oxley, ISO, GAMP Methodologies and general Software Development Standards.
• Formulate SW product quality plans based on results of risk/hazard analysis.
• Present and defend software validation documentation in internal as well as external audits.
• Assists with periodic audits of IT systems and compliance activities as per the Global Computer Validation Management Policy, and provides summary reports to management as required.
• As required, assist or lead in the prompt implementation of Non-Conformance resolution, and Corrective & Preventative Action(s) (CAPA) through Trackwise.
• Develop quality system metrics to support Management Reviews.

Minimum Requirements/Qualifications:
• Bachelors Degree in Bioinformatics, Computer Science, or Math; Master’s degree preferred.
• Minimum of 3-6 years experience in a Quality Assurance/Software Validation role for medical device or pharmaceutical manufacturing. (or 4 years with Masters Degree)
• Able to prioritize projects and manage resources to meet organizational goals and objectives.
• Depth of knowledge of lifesciences regulations including 21 CFR Part 11, Annex 11, GAMP 5 and related best practices for compliance.
• Extensive experience developing and creating computer software validation deliverables, e.g. risk assessments, validation plans, procedures, testing and documentation.
• In depth knowledge of System Development Life Cycle development methodologies.
• Experience with at least two(2) end to end Validation Lifecycle Implementation for software systems.
• Experience with Quality Management Systems like Trackwise, Master Control and Laboratory Information Management System (LIMS).
• Experince with Infrastucture validation (Servers, Database, Backup tapes etc.) a plus.
• Must be able to work independently with minimal supervision.
• Must be self-motivated, detail oriented and able to multi-task.
• Must possess excellent communication (oral and written) and forward-thinking skills.
• Must be comfortable in a fast-paced, demanding and dynamic work environment.

This position has not been approved for relocation assitance.


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