Computer System Validation Specialist - Exton, United States - Frontage

Description

Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to achieve their drug development goals.

We have enabled many innovator, generic, and consumer health companies of all sizes to file IND, NDA, ANDA, BLA, and 505(b)(2) submissions in global markets allowing for the successful development of important therapies and products for patients.

We are committed to providing rigorous scientific expertise to ensure the highest quality and compliance. We have successfully assisted clients to advance hundreds of molecules through development to commercial launch in global markets.
General Description
Computer System Validations
Provide computer system validation support (CSV) for both instrument software applications as well as enterprise applications.

Conduct full GxP 21 CFR Part 11 computer software validations, including Part 11 Gap analysis, Risk Analysis, Preparation of User Requirements, Configuration documents, Validation Protocols, Test Scripts and Validations reports.

Work closely with validation team and laboratory technical expert as well as QA during document reviews.
Responsible for evaluating software upgrades for needed additional testing under change control procedures and provide updates to management.
Collaborate and communicate with other project team members and stakeholders effectively.
Reviews and manages the documentations for projects assigned.
Manages and reviews the testing activities with the application team during nay release.
Authors test scripts and testing scenarios
Provide computer system validation support (CSV) for both instrument software applications as well as enterprise applications.
Performs risk assessments / Gap Analysis for applications that need to be validated for GxP 21 CFR Part 11 and ISO27001 Information Security
Participates in any external or client audits where application concerned is involved.
Maintain good documentation practice in all applicable areas of responsibilities .
Requirements
3 ~ 5 years of experience as a computer system validation specialist
Knowledgeable of regulations and guidance's on computer system validation

Familiar with laboratory applications such as Watson LIMS, IDBS Electronic Workbook, Sciex Analyst, Molecular Devices SpectraMax and MSD Discovery Workbench.

Can exercise strong problem-solving skills, and analytical thinking.
Has exceptional written and verbal communication skills.
Has the ability to liaise with different departments and multiple business disciplines.
Can confidently provide support and user training across departments

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Frontage Laboratories Inc. is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

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