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)