QA Specialist Serialization
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Our client, a leading global pharmaceutical organization, is seeking an experienced QA Specialist to serve as a global Quality Representative. The role focuses on consolidating international serialization systems and defining quality requirements for a new automation integration layer across various manufacturing sites.
- Serve as the primary Global Quality SME for serialization and automation programs across the organization.
- Lead the development and consolidation of a single global SOP suite for serialization to replace existing site-level documentation.
- Translate international regulatory requirements into site-level quality controls and procedural standards.
- Ensure global alignment of procedures and lead training activities for quality and operations staff.
- Define global quality requirements and documentation for new automation integration layers as projects progress.
- Manage stakeholders across Global Quality, IT, Regulatory Affairs, and Operations to ensure program compliance.
- You have a Bachelor's degree in Pharmacy, Life Sciences, or Engineering.
- You bring 8+ years of quality experience in the pharmaceutical industry with 3+ years focused on global serialization or track-and-trace projects.
- You possess strong skills in SOP authoring, change control, and risk assessment.
- You have knowledge of regulatory requirements including EU Falsified Medicines Directive, US DSCSA, and China NMPA.
- You bring a technical understanding of manufacturing automation and Data Integrity.
- You have excellent stakeholder management and influencing skills within a global, virtual team environment.
- You are fluent in English.
Nice to Haves
- Possession of an advanced degree in a relevant scientific or technical discipline.
- Practical experience with national repository models for medicinal traceability.
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