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Aug 14, 2017
QA and Validation Jobs
Sr. QA, Compliance and CSV specialist
Boston, MA
Tropisys Information Systems has a project that requires a senior QA, Compliance and CSV specialist in Boston, MA. This position will be responsible for overseeing quality, compliance and governance of a Computer System Validation (CSV) project and working against SOP's, SLC and FDA regulatory guidelines. Working directly with multiple business units across the GxP space, this person will be an integral part of the validation project teams. This project team includes 3rd party solutions and resources, SaaS, Cloud, COTS etc. This projects is part of an ERP implementation which will have multiple integrations. The project is focused on the SCM (supply chain management) module which has GxP implications.
Key Responsibilities
* Acting as an independent reviewer and approver for all validation documentation; Solution Impact Analysis, Supplier Assessments & IT Vendor Questionnaires, Commissioning & Qualification documents, Validation and Test plans, Specifications (e.g. User Requirements Specification, Functional/Config Specification, etc.), User Acceptance Testing, Traceability Matrices, and Validation Reports
* Provide guidance to project teams during the planning and definition phases to develop a validation approach commensurate to the risk level assigned to the system
* Supporting role for computer system/software vendor audits
* Oversee execution of validation protocols for GxP impacting systems. Lead/coordinate investigations into failures to meet acceptance criteria and determine appropriate corrective actions. Manage related CAPAs and Deviations, as needed
* Own, provide assessments, or review and approve validated system change control records
Plan, schedule and conduct Periodic Reviews of validated systems as part of Internal Audit.
* Support the development, expansion, and improvement of Standard Operating Procedures, Work Instructions, and related templates for the GxP Regulated Computerized System life cycle processes.
Critical Success Factors
* Working experience on Computer System Validation projects from cradle to grave. Proven ability to oversee and evaluate all lifecycle phases and corresponding documentation.
* ERP systems knowledge - Oracle SCM would be preferred.
* Knowledge of and experience with GXP Software Validation, applicable FDA and EU regulations, ICH guidelines, and applicable standards.
* Ability to work well and collaborate with a wide range of team members: IT, vendors, business process experts, regulatory, and multiple stakeholders, especially under stress and with changing priorities
* Experience in managing external vendors (SaaS, IaaS) through evaluation, audit, validation execution, implementation, deployment and ongoing maintenance/change control/support.
* Proven ability to work with a high level of integrity, accuracy, and attention to detail
* Strong technical/analytical skills to identify and solve problems.
* Self-motivated, assertive, and self-confident with the ability to act with urgency and passion.
* Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
* Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
* Proactively seeks out and recommends process improvements.
* Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
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