Healthcare Project Management Quality Assurance (QA) Specialist
Primary Locatie: HERKENBOSCH, Nederland Job ID R24029910 Postcode 6075 GXOntdek je volgende kans bij een Fortune Global 500-organisatie. Stel je innovatieve mogelijkheden voor, ervaar onze belonende cultuur en werk met getalenteerde teams die je helpen elke dag beter te worden. We weten wat er nodig is om UPS een succesvolle toekomst te bieden: mensen met een unieke combinatie van vaardigheid en passie. Als je de kwaliteiten en drive hebt om jezelf of teams te leiden, staan er rollen klaar om je vaardigheden te cultiveren en je naar het volgende niveau te brengen.
Functieomschrijving:
Job Summary The QA specialist position for project management contains different tasks related to new client opportunities, buildings and other projects next to supporting new client implementations. In this role you work together with different other internal UPS actors to build the best solution for a potential client or improve current processes.
Responsibilities:
- Assists with the implementation and maintenance of the Quality Management System (QMS) in accordance with ISO: 9001 and ISO: 13485 standards, and in compliance with the EU GMP and EU GDP Guidelines.
- Applies his/her knowledge, skills and tools in assessing and supporting Projects from the quality and compliance point of view.
- Supports the Project Team with projects such as:
- Setting up the QMS in a new Building,
- Assessment of new (Transport Only) Client opportunities,
- Implementation of new (Transport Only) Clients,
- Implementation of new Equipment,
- Implementation of new Processes,
- Implementation of new Suppliers.
- Supports External Audits within the scope of Project Management (e.g. new Client Audits, initial Regulatory Inspection).
- Conducts risk assessments on QMS processes in order to identify and mitigate any risks.
- Supports with process validation on new processes and new Buildings.
- Support with all facets of set up a new Building and with new Clients.
- Keeps track of the projects, monitors the progress and identifies best practice and lessons learned.
- Communicates project statuses verbally and in writing
- Works together with other EU project QA team members to improve the projects and client implementation process.
- Coordinates process improvements projects within the applicable departments and other EU Countries.
- Supports the Project Team with different tasks such as:
- Getting to know QMS and providing any training,
- Creating Change Controls for any Projects,
- Reviewing and completing other documentation like questionnaires, assessments etc.
- Implements the Supplier Management Program as part of the Project Management in Europe.
- Supports other European countries with the qualification of their Suppliers and setting up the Supplier Management structure.
- Performs internal and external audits
- Creates audit reports and presents findings to UPS Operations/ QA Management and Responsible Person(s).
- Evaluates Audit responses and creates Audit Improvement Plans (AIP).
- Monitors and trends the outcome of the audit findings.
Qualifications:
•Education: Secondary vocational education (MBO level in the Netherlands).
•Strong communication skills, stress resistant, able to speak and write in English and Dutch
•Working knowledge of various computer systems (specifically MS Excel) is needed.
•High focus on Healthcare compliance.
•Knowledge of Microsoft Office (Excel, Word, Outlook, Access).
•Experience with ISO 9001 and ISO 13485 standards is an advantage.
•Knowledge of GMP and/ or GDP guidelines is an advantage.
•Relevant working experience in the Logistics industry.
•Able to work within time-limits (deadlines), persistent
• Ability to work with different electronic system
• Ability to perform internal and external audits
Werknemerstype:
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