SAP Quality Integration Expert - Barcelona, España - MIGx

MIGx

Empresa verificada

Barcelona, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Our company is rapidly growing and now we are looking for a SAP Quality Integration Expert, as a member of the Global Quality team, will be involved in the design, integration qualification and validation of a new global ERP system (SAP).

Tareas

Integration the organization's quality management system into SAP
Oversight the quality for all processes of Operations, Procurement and/or Supply Chain departments towards implementation, SPOC for quality and for the setup of the SAP Quality Module
Ensure compliance with customer quality standards as well as GMP requirements throughout the design, validation and implementation of the system.
Responsible for review and approval of documents such as URs, risk assessments, and validation documentation (validation plan, IOQs, qualification reports etc).
Definition of the required procedures to be generated as well as those needed to be updated as a consequence of the system installation.
Approval of the system relevant SOPs acting as the quality contact.
Handling changes relevant to the project as required and in collaboration with the team and other departments.
Handling deviations relevant to the project in collaboration with the impacted stakeholders. Provides assistance for deviation handling, investigations and necessary CAPAs were needed.
Collaboration with Quality / Validators partners to ensure a smooth deployment of the system to the end user.
Providing training to all Quality team on the system functionality and operability. Assists other departments into setting up training for the other modules.
Identification of discrepancies throughout the design and/or implementation phase and escalates accordingly in order to ensure compliance with the company's standards.

Requisitos:

Bachelor degree, Master degree in biotechnology, pharmacy, life science and / or experience in SAP projects
3 to 5 years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role
Strong background in GMP regulations and Quality Systems
Expertise in computerized system validation
General knowledge of manufacturing processes and operations as well as material handling and supply chain requirements
Strong team orientation
Structured, focused and wellorganized working attitude; openminded for new ideas and suggestions; agile, highly motivated and dynamic drive.
Solutionoriented.
Experienced in representing Quality and Compliance in the operational manufacturing environment.
Ability to oversee project execution to identify quality and compliance gaps.
Ability to prioritize and manage work to critical project timelines in a fastpaced environment.
A good operational level of English.
German is a plus
Ability to communicate fluently with technical teams, both internal (company) and external (customers)
Proactivity, problemsolving, and conflict resolution ability

Beneficios

Hybrid work model and flexible working schedule that would suit night owls and early birds
Excellent compensation package + Social Benefits
Free English classes
Possibilities of career development and the opportunity to shape the company future
An employeecentric culture directly inspired by employee feedback your voice is heard, and your perspective encouraged
Different training programs to support your personal and professional development
Work in a fast growing, international company
Friendly atmosphere and supportive Management team