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US-MA-Cambridge: Lead QA Specialist
To see other opportunities,
please visit http://sqa.fyicenter.com
Date: 10-Jun-2008
Lead QA Specialist
Key Responsibilities:
The individual will serve as an IS Quality/Validation subject matter expert (SME) and provide guidance on validation and testing strategies for each implementation project based on system risk, complexity, and other relevant factors. This includes, but is not limited to:
* Represent IS Quality/Validation on projects; and management teams as appropriate
* Leadership on validation strategies for system implementations and changes to ensure solutions are demonstrated as fit for purpose
* Partner with the Vertex system implementation teams to ensure Part 11 compliance
* Provide consultation and support as required to meet project goals and objectives.
* Perform Quality review and sign-off of computer system control documents
* Review requirements packages and provide compliance & quality inputs to the requirements engineering process
* Manage multiple simultaneous validation, revalidation, and change control activities.
* Provide compliance/validation leadership to project teams and validation contractors
* Review and approve validation and test protocols for adequacy and completeness.
* Proactively identify opportunities for process improvement in the Systems Life Cycle
* Author and/or contribute to the development and implementation of Vertex Policies, SOPs, Work Instructions, Forms, and Templates surrounding the Vertex Systems Life Cycle for on-boarding and validating computer systems subject to 21 CFR Part 11.
* Independently solve Systems Life Cycle related problems and implements corrective actions as needed
* Work to maintain the validated state of Vertex computer systems by participating in the change control process
* Maintain validation related metrics and reports performance to management
* Participate in and/or support regulatory inspections as assigned
* Participate in and/or support software vendor audits as assigned
* May supervise other IS Quality/Validation staff
* Perform other duties as assigned
Requirements
Minimal Requirements
* This position requires a B.S. (or equivalent degree) and 8+ years of relevant work experience as well as a practical working knowledge of validation, quality assurance, information systems, and risk management best practices.
* Knowledge of GCP, GLP, cGMP, HIPPA regulations is required with an emphasis on 21CFR Part 11.
* Experience with System Life Cycle models (Waterfall, Rapid Application Development, Spiral Model, etc.) is needed.
* Excellent communication, interpersonal skills, and customer focus are also essential.
* At least 5 years of direct experience writing and executing validation documentation required
* At least 2 years of project management experience in the pharmaceutical/biopharmaceutical industry preferred
* Experience with validating electronic records management, quality, and supply chain (ERP) systems preferred
* Must be able to demonstrate good communication skills both oral and written
* Must be able to demonstrate excellent customer service skills
* Must have demonstrable flexible & out of the box thinking approach to problem solving and process improvement
* Must be well organized and willing to work as part of a team
* Test automation experience a plus
* Knowledge of the application of ITIL good practices for IT Service Management preferred
For more information, please write to us.
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com
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