Posted on Aug 28, 2019 by Randstad Multilingual Recruitment Banen
We are looking for an enthusiastic Product Owner (PO), contingent worker in the area of Document Record control with experience with System Validation and experience in Business Quality Management Systems (ISO 13485), FDA (21CFR) regulations.
You will support the development, implementation and drive continuous improvements of the standardized business capabilities for the area Document Record control. Process custodian and ensures adoption of proven practices. Capture learnings and actively share success within your network.
Defines and establishes a lean practice (tools, methods, standards, competency and tool performance) for System validation lifecycle control of the related Software systems.
Establish lean practices around Quality System Software Controls for the related Document Record Control systems in line applicable policies and procedures
Ensure that Document Record Control applications and related infrastructures are validated for their intended use by a controlled and documented process
Ensure that changes to existing software or infrastructures are validated before approval and use
Ensure documentation of software validation activities and results for all phases of the software system Life cycle
Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the software validation packages of software applications which automate Quality System processes.
Authors, reviews and or approves validation deliverables for non product software, including but not limited to validation plans, requirements, test plans protocols results, risk assessments, traceability matrix and summary reports.
Collaborate in business transformations to provide expert support in diagnosis of processes within area of expertise, suggest proven practice solutions and ensure implementation of the suggested processes
Collaborate with IT and EIM to drive selection design and configuration of right technology and data solutions
Mapping new solutions and ways of working and translate these into an implementation plan.
Being a change agent by clarifying the linking impact of the new solutions and ways of working including the IT, data, people, process solutions.
Facilitate learning, provide process training (competency development) and prepare end user documentation.
Collect and review process change and improvement proposals from the organization, bring forward relevant change proposals to the Business Process Owners (BPOs), support local improvements where necessary
Actively interact with Business Process Experts (BPEs) to share knowledge on improvement practices
Provide expert support in diagnosis of processes within area of expertise to perform process gap analyses, suggest enforce the selected best practice solutions and ensure compliance with the standardized suggested processes
You are part of the Philips Q R PQMS capability and you will be part of the Center of Excellence Controlled Documented Information (CoE CDI) team existing of 10 persons dealing with activities like Quality Management, System Validation, Training and Change, Document Record Control.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. The offer is based on a temporary contract (1 fte) until end of 2020.
We are looking for
Our ideal candidate has the following profile criteria
Minimum 7 10 years of experience in validation of computer systems and systems security and control including supervision of a technical professional staff.
Minimum of 6 years of related experience in Document Record Control and Change management field
Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFR, ISO 13485, and GAMP 5.
Minimum of 7 computerized systems implementations comprised of multiple application types, in a regulated environment.
Demonstrated ability to interact and communicate (both oral and written) with junior project team organizational members, business leaders and senior executives.
Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections
Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection to ensure a comprehensive documentation package is created and maintained.
Effective judgment and decision making skills, typically made under stressful situations.
Competency in project management and the execution of multiple projects.
Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.
Ability and willingness to travel 20 domestic and international.
Fluent in English.
The max. rate for this role is 90 per hour
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