The tasks of the DC Service team are to develop an end-to-end process overview for every customer, escalate operational issues to EDN when needed, be the hearth of every project within the DC and support daily activity with QA and safety expertise.
The compliance coordinator has a good knowledge of the DC processes and their GxP-criticality, as well of the quality system and quality requirements. He/she supports all department heads in ensuring their processes and staff/teams are fully compliant with the quality system of the department. He/she ensures that all changes/projects coming up in the department (equipment and process projects, new quality / temp control / … requirements - from internal or external) are assessed and integrated in line with the quality systems requirements. He/she further drives the quality awareness creation in the department.
In this role he/she:
* Keeps track of the QA KPI's (including QIP and QMR meetings)
* Coordinates the COC and CAPA forum.
* Represents the DC in the different change boards for equipment and local IT-systems (WCS and eWM)
* Coordinates complaints management and events within the DC: makes sure root causes are identified for each, in support of every operational responsible, action plans are defined and executed on time / first time right.
* Manages QA related documents: life cycle, improvements and updates, communication (SOP, WI, FRM, …)
* Sets-up and maintain the process documentation procedures
* Gives training on QA related topics within the DC and organizes awareness programs
* Is the spokesperson for QA within the DC for internal and external audits
* Is the business responsible for the Audit readiness of the DC.
* Plays a key role in process and QA related projects (quality system, temp control, supplier management, new process introductions, repack, …).
* Lead different projects in the area of compliancy and quality.
EDUCATION & CERTIFICATIONS:
Bachelor's degree or equivalent experience ( 8 years +)
DESCRIBE THE KNOWLEDGE, SKILL, ABILITY AND EXPERIENCE REQUIRED:
1. J&J QA guidelines know-how and experience
2. Experience with J&J quality related software
3. Ability to rigorously follow procedures
4. Structure and organization
5. Good communication skills, ability to create a real QA focus within the organization
6. Ability to convince and represent authority
7. Ability to build effective collaborative/partnering relationships with internal and external stakeholders
8. Good trainer skills
9. Sense of details
10. Fluent in Dutch and English
Janssen Pharmaceutica N.V. (7555)