Shire Jobs

Job Location

Rotterdam

Job Description

We are seeking our Quality Specialist to support the Go-To-Market Quality Assurance team in order to ensure compliance with all applicable pharmaceutical regulations.

The Quality Specialist should:

• Support the Go-To-Market Quality Assurance team to ensure Quality Management System (QMS) is implemented and maintained as the examples below

• Preparation of batch release documentation

• Training follow-up (onboarding and continuous training and distribution of local documentation for training)

• Compile quality KPI (Key Performance Indicators)

• Tracking and follow-up on quality system records such as Change Controls, deviations, CAPAs and record handling within P&G quality systems

• Follow-up on renewal of Quality Agreement

• Support approval/qualification of suppliers/customers

• Product Quality Complaint follow-up

• Support publication of Quality Management System documentation in P&G quality systems

• Support archiving activities

• Answer to requests from Customers / Business on ad hoc base

• Support preparation of the Product Quality Review assessment and Quality management Review

• Raise immediately any concerns to the Qualified Person-Responsible Person as appropriate

• support eQMS and Rubix projects as needed

• support EU QMR preparation as needed

These activities should always be in full compliance with the Dutch Healthcare current regulations, notably the GxP (GDP, GMP, GCP, GLP, etc.).

Job Qualifications

• Bachelor’s degree in health-related science, life science, pharmacy or medical degree

WORK EXPERIENCE:

Ideally Quality Management System experience or relevant experience in pharmaceutical and/or food industry

ADDITIONAL REQUIREMENTS:

• Strong customer orientation

• Demonstrated good interpersonal, communication, organizational, presentation skills, influencing, and problem-solving capabilities

• Ability to work independently and manage time efficiently and effective

• Awareness of cultural differences and impacts of team/personal behavior

• Strong quality orientation including the ability to focus on details and adherence to standards while maintaining a business perspective

• THE FOLLOWING SKILLS ARE A PLUS (NOT MANDATORY, CAN BE LEARNT DURING ASSIGNMENT):

• SAP tool knowledge

• Veeva tool knowledge

• German language

PERSONAL SKILLS:

• Team spirit

• Autonomy

• Prioritization

• Well-organized

• Cross-functional collaboration

Job Schedule

Full time

Job Number

R000118605

Job Segmentation

Recent Grads/Entry Level (Job Segmentation)