QA Specialist Serialization & Automation

Pauwels Consulting; Beerse; On-site; EUR 90,000 - 120,000; Full time

Job summary

Pauwels Consulting is seeking an experienced QA Specialist for a global pharmaceutical client. You will serve as the Global Quality SME for serialization and automation programs across the organization.

The role focuses on consolidating serialization systems, defining quality requirements for a new automation layer, and aligning procedures across manufacturing sites. English fluency and knowledge of EU FMD, US DSCSA, and China NMPA are essential.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, or Engineering.
• 8+ years of quality experience in the pharmaceutical industry with 3+ years focused on global serialization or track-and-trace projects.
• Strong skills in SOP authoring, change control, and risk assessment.
• Knowledge of regulatory requirements including EU Falsified Medicines Directive, US DSCSA, and China NMPA.
• Technical understanding of manufacturing automation and Data Integrity.
• Excellent stakeholder management and influencing skills within a global, virtual team environment.
• Fluent in English.

Responsibilities

• 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.

Skills

Serialization

Track-and-trace

SOP authoring

Change control

Risk assessment

Stakeholder management

English

Education

Bachelor's degree in Pharmacy

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Job description

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.