Global QA Specialist – Serialization & Automation Standards

Panda International; Beerse; Hybride; EUR 80 000 - 100 000; Plein temps

Résumé du poste

Panda International is seeking an experienced QA specialist to serve as Global Quality Representative for two cross-functional programs focusing on serialization and manufacturing automation. The role is execution-focused and involves leading the global alignment of serialization SOPs and regulatory compliance activities.

The candidate will collaborate across Global Quality, IT/Digital, Regulatory Affairs, Operations, and MAH stakeholders to implement worldwide health authority requirements and

Qualifications

• 8+ years in Quality within pharmaceutical/biotech manufacturing.
• 3+ years responsible for serialization and/or track-and-trace at global scale.
• Hands-on experience writing and implementing global GxP SOPs.

Responsabilités

• Act as Global Quality SME and primary QA contact for regulatory and compliance matters on both program teams.
• Lead development of one consolidated Global Serialization SOP suite that supersedes local site documents.
• Translate regulatory requirements into site-level quality requirements and procedural controls, and ensure SOP alignment.
• Lead training and competency activities on global procedures for QA and operations staff.

Connaissances

Quality management

Serialization experience

GxP SOPs

Stakeholder management

Formation

Bachelor's degree in Pharmacy, Life Sciences, Engineering, or comparable

Outils

Global SOPs

Description du poste

Panda International is seeking an experienced QA specialist to serve as Global Quality Representative for two cross-functional programs focusing on serialization and manufacturing automation. The role is execution-focused and involves leading the global alignment of serialization SOPs and regulatory compliance activities.

The candidate will collaborate across Global Quality, IT/Digital, Regulatory Affairs, Operations, and MAH stakeholders to implement worldwide health authority requirements and