Business Process Expert
We are looking for an enthusiastic Business Process Expert (BPE), contingent worker in the area of Document & Record control with experience in Business Quality Management Systems (ISO 13485), FDA (21CFR) regulations and experience with System Validation.
Develop, implement 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, process and process performance) for SW validation & lifecycle control of the related SW systems.
• 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
• Lead or support process implementation projects and ensure processes are implemented as designed
• 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.
• 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
• Continuously monitor process performance, analytics and identify opportunities for improvement
• 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 other BPE’s to share knowledge on improvement practices
• 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 SW validation activities and results for all phases of the software system Life cycle
• Executes and /or manages SW validation & control activities.
• Ensures the accuracy, completeness and compliance of SW validation deliverables by reviewing the SW validation packages of SW applications which automate Quality System processes.
• Authors, reviews and/or approves SW validation deliverables for non-product SW, including but not limited to SW validation plans, requirements, test plans/protocols/results, risk assessments, traceability matrix and summary reports.
You are part of the 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, CAPA, Management Review and Change, Document & Record Control.
Our ideal candidate has the following profile criteria:
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
• Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant discipline. Viewed as an expert in the field. May have a leadership role. Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Has expert level knowledge of company products and services.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers. Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
• Master’s degree with ? 5 years of related experience.
• Minimum of 6 years of related experience in Document & Record Control and Change management field
• Minimum of 4 years of experience in Business Quality Management Systems (ISO 13485), FDA (21CFR) regulations and Computer Systems Validation
• Familiarity with Document and Change Management System tools
• Experience running effective process improvement projects
must have items
– BPE / Business Product Owner (in the area of Document & Record and Change control & Software System Validation)
nice to have items
- Project management
Please send us asap your recent CV + a motivation for this role, both in English, together with your availability/planned vacations and all-in hourly rate VAT (BTW) excluded.