QA Specialist

Panda International; Beerse; Hybrid; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality management

Serialization experience

GxP SOPs

Stakeholder management

Ausbildung

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

Tools

Global SOPs

Jobbeschreibung

About the Role

We are looking for an experienced QA specialist to act as Global Quality Representative on two cross-functional programs within a global quality organization. The main focus is serialization, with a secondary focus on manufacturing automation. You will join a team of 4 that works mostly virtually. This is an execution role, not a management role.

Upgrade and consolidate existing serialization systems and implement regulatory changes and upcoming health authority requirements worldwide. You will author a single global set of serialization procedures that replaces site-level documents, and lead their global alignment and deployment. System/software validation is not in scope.

Program 2 (secondary focus): Manufacturing Digital Connect

A new automation integration layer. You will first assess its quality impact, then define global quality requirements and documentation as the project progresses.

Key Responsibilities

• 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 (procedures and work instructions) 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

What You Bring

• 8+ years in Quality within pharmaceutical/biotech manufacturing, including 3+ years responsible for serialization and/or track-and-trace projects at global scale
• A QA background (mandatory), with serialization experience from the quality side
• Hands-on experience writing and implementing global GxP SOPs
• Practical knowledge of the EU Falsified Medicines Directive (EMVS/EMVO), US DSCSA requirements, and China NMPA traceability expectations (or experience with national repository models)
• Technical understanding of serialization; manufacturing automation and data integrity knowledge preferred
• Strong SOP authoring, change control, and risk assessment skills
• Excellent stakeholder management and influencing skills across Global Quality, IT/Digital, Regulatory Affairs, Operations, and commercial/MAH stakeholders
• Bachelor's degree in Pharmacy, Life Sciences, Engineering, or comparable (advanced degree preferred)
• Fluent English, written and spoken

Details

• Start: ASAP
• Duration: 12 months from start date
• Hybrid: 3 days onsite, 2 days remote
• Full-time (100%); 80% (32 hours/week) may be considered