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Healthcare Quality Assurance Specialist - San Fernando de Henares, España - United Parcel Service Of America
Descripción
Explore your next opportunity at a Fortune Global 500 organization. Envision innovative possibilities, experience our rewarding culture, and work with talented teams that help you become better every day. We know what it takes to lead UPS into tomorrow—people with a unique combination of skill + passion.If you have the qualities and drive to lead yourself or teams, there are roles ready to cultivate your skills and take you to the next level.
Job Description:
Do you want to work for a leading multinational in the pharmaceutical logistics sector as a Healthcare QA Specialist? Do you have experience with GMP and GDP? At UPS Healthcare we are looking for a Healthcare QA Specialist.
Assists with the implementation and maintenance of the Quality Management System (QMS) in accordance withISO:
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 Client opportunities,Implementation of new 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 Design Qualification in a new Building and with new Clients.
Keeps track of the projects, monitors the progress and identifies best practice and lessons learned.
Coordinates process improvements projects.
Supports the Project Team with different tasks such as:
Getting to know QMS and providing any training,Creating Change Controls for any Projects,Completing the Design Qualification assessment
KEY INTERACTIONS Internal:
Project ManagerResponsible PersonOperations ManagementQA Department / Document Control DepartmentSolutions / ImplementationsSecurityBaSe TeamProcurement DepartmentValidation DepartmentIT/ FUR DepartmentExternal:
Regulatory AgenciesClientsSuppliersThird Party AuditorsKNOWLEDGE AND EXPERIENCE
Education Level:
At minimum a Bachelor's Degree in Science or equivalent industry experience.
Preferable Degree in Pharmacy, Chemistry, Technology and/ or Food Studies.
Specialised Knowledge:
Experience with
ISO:
9001 and/or
ISO:
13485 standards is an advantage.
Experience with GMP and/ or GDP guidelines is an advantage.
Experience with Supply Chain Industry is an advantage.
Experience with Root Cause Analysis tools (e.g. 5 why's, FMEA) is an advantage.
Experience with Project Management is an advantage.
Skills:
Proficiency in English (written and verbal). Proficiency in second language preferred.
Strong verbal and written communication skills, to present recommendations and report back to different levels within the organization.
Preferably experience in technical writing of documentation.
Proficiency in Microsoft Office (MS Word, Power Point, and Excel).Knowledge of electronic Quality Management System is an advantage.
Ability to prioritize decisions which may have a significant risk for the company.
Ability to create networks and collaborate with various internal and external teams.
Coordination of improvement projects where needed.
Strong organization, time management and planning skills.
Flexible in working hours.
How we recruit Committed to a policy of treatingindividualsfairly and recruiting, selecting, training, promoting and compensatingbasedonmerit, experience and otherwork-relatedcriteria. We do notdiscriminateagainstanyapplicantbasedonage, race, religion, sex, disability, sexual orientationorgenderidentity.
Employee Type:
Permanent UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.
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