Freelance Senior Quality Consultant – Person‑in‑Plant
ProPharma · Serbie Centrale
Description du poste
About the role
ProPharma is seeking a freelance Senior Quality Consultant to support Person‑in‑Plant activities for a leading life‑science client across CDMO sites in the UK and EU. The role starts immediately, runs for an initial three‑month period (1.0 FTE, 40 h/week), and includes travel to partner sites for two to three weeks.
Key responsibilities
- Lead and manage routine Quality Management Reviews (QMRs).
- Provide quality oversight during Process Performance Qualification (PPQ) for clinical and commercial products.
- Conduct audits, CAPA, deviation handling and other QMS tasks.
- Coordinate mock‑inspection readiness activities, including preparation, coaching and documentation review.
- Support inspection and audit readiness for clinical and commercial manufacturing operations.
- Collaborate with cross‑functional teams to address and resolve quality risks.
- Review quality systems, documentation and manufacturing activities for GMP compliance.
- Act as the QA subject‑matter expert for assigned Person‑in‑Plant projects.
Required profile
- BSc or higher in a life‑sciences discipline.
- Extensive experience in Quality Assurance within the life‑sciences industry.
- Prior experience as a Person‑in‑Plant or supporting Person‑in‑Plant activities.
- Experience managing CDMO partners is highly preferred.
- Fluent English communication.
- Based in the UK or EU and able to travel to sites as required.
Required skills
- Quality Management Review (QMR) execution.
- Process Performance Qualification (PPQ) oversight.
- Audit, CAPA and deviation management.
- Mock‑inspection preparation and execution.
- GMP compliance assessment.
- Cross‑functional stakeholder collaboration.
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ProPharma
Serbie Centrale
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