Lead the setup of the verification of a multidisciplinary (technical) product
Over de functie
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 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, CAPA, Management Review and Change, Document & Record Control.
We are looking for
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
We will boost your career through personal and technical growth. We’ll support you by offering a personal coach and the possibility to follow courses and training via our highly recommended Yacht Academy. We’ll offer interesting benefits and a market conform salary. You’ll become member of the team of professionals who share your education, ambitions and your competencies. This will enable you to interact with your colleagues from Yacht in your own technology language! You’ll become a member of the yacht network, which stretches the high tech industry. You will be challenged by your peers. As a result you’ll be able to keep your knowledge and skills up-to-date!
Consumer Lifestyle is delivering on Philips' vision to make the world healthier and more sustainable through innovation. Their investment in innovation and local business creation enables them to deliver a stream of locally relevant, meaningful innovations. They have a leading global brand, which is highly trusted across the world.
Voor meer informatie neem je contact op met Bram Geerets via telefoonnummer 06-13888330
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.