Senior Specialist External Quality

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Job Function
Quality
Job Sub Function
Customer/Commercial Quality
Job Category
Professional
All Job Posting Locations
Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Latina, Italy
Job Description
J&J; Innovative Medicine is recruiting for a Senior Specialist External Quality to be located in Latina (IT), Beerse (BE) or Allschwil (CH). This role will report to the Sr. Manager External Quality. External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. In this role, you will play a crucial part in maintaining the highest quality and compliance standards for our Synthetic products, specifically focusing on Drug Products, produced at external manufacturing sites. You’ll collaborate closely with our External Quality Site Lead and be a champion for quality in everything we do The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities




- Key Responsibilities: Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
- Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
- Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
- Identify, communicate and elevate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
- Support qualifica

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