Supplier Quality Specialist - QC - Compliance

SUPPLIER QUALITY SPECIALIST - LEIDEN, NETHERLANDS/11 MONTHS CONTRACT/UP TO 50 EUR (PER HOUR)

Quality and Compliance support the ESIQ SQ quality manager, supporting functions and activities including Quality assurance review and preparation functions (such as Change Control, Validation), Compliance audit activities, due diligence assessments, supporting creation and management of supplier development plans and organizational structures. Supports Quality Manager in ensuring business, quality and compliance goals adhere to J&J, JSC and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the JNJ credo and quality values in contact with the third-party manufacturers and will comply with the JNJ regulations for ethic and business conduct in order to strengthen the reputation of J&J.

COMPETENCIES/SKILLS REQUIRED:

- Supporting the planning, execution, and documentation of the qualification and monitoring for third party suppliers who are delivering excipients, raw or packaging materials, to the Janssen Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively
- Supporting surveillance on the quality and compliance status for all third party supplied raw materials, packaging materials, intermediates, excipients, and APIs.
- Management of Change in Trackwise (change assessor, action executioner)
- Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning suppliers.
- Supporting execution of establishment and periodic review of Quality Agreements
- Supporting establishment and revision of Qualification Statements, quarterly performance metrics, and annual qualification classification for suppliers
- Support API manufacturers during health authority inspections
- Supporting activities related to Initial assessment and qualification of suppliers for new product introductions
- This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC ESI Quality with the quality unit of suppliers.
- Support Quality processes within the API manufacturing site in relation to external suppliers
- Support internal site Regulatory inspections
- Management of Change in Trackwise (change assessor, action executioner, )
- Supporting ESIQ-SQ contact point for the API sites in the EMEA
- Supporting all activities of SQ Quality Manager

EXPERIENCE

- HBO/Bachelor
- Experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with experience in external manufacturing operations or Quality Assurance for external manufacturing
- Exposure to regulatory authorities inspections
- Deep understanding of Quality processes and systems
- Strong plus: experience with Trackwise software

THE COMPANY

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

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