Proclinical is seeking a Quality Auditor to support the operational implementation of artwork changes for external Contract Manufacturing Organizations (CMOs) in the EU. This role focuses on ensuring compliance with the new Veterinary Regulation (EU 2019/6) and adapting product packaging and quality processes accordingly. You will work closely with cross-functional teams, including global artwork departments and CMOs, to manage change controls and ensure timely project execution.
Responsibilities:
* Act as the EMQ Site Point of Contact (SPOC) for the QRD 90 project.
* Collaborate with central Reliance QRD SPOC, global artwork departments, and GRA Operations.
* Serve as the primary liaison with project contacts at CMOs.
* Manage change tasks within the Reliance quality management system.
* Participate in stakeholder meetings and ensure timely task execution.
* Develop and follow up on new technical specifications as needed.
* Execute the Quality Representative role for assigned projects.
* Create artwork switch plans in collaboration with global teams and CMO contacts.
* Identify and escalate challenges or risks related to project timelines and resources.
Key Skills and Requirements:
* Strong knowledge of Good Manufacturing Practices (GMPs) in the pharmaceutical industry.
* Familiarity with compliance requirements for change management and control.
* Experience in Quality-GMP or Regulatory environments.
* Proficiency in managing transversal projects and working in multicultural, cross-functional teams.
* Fluent in English with excellent adaptability and integration skills.
* Results-oriented mindset with experience in artwork management.
* Bachelor's degree in Science, Pharmacy, Engineering, or a related field.
If you are having difficulty in applying or if you have any questions, please contact Numhom Sudsok at n.sudsok@proclinical.com.
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