Qualified Person (QP)
Location: West Germany (On-site / Hybrid depending on candidate location)
Industry: Pharmaceutical Manufacturing / GMP
Join a well-established pharmaceutical organisation with a strong European presence and a clear patient-focused mission. This is an excellent opportunity for an experienced Qualified Person (QP) to take responsibility for batch certification and release activities, ensuring full compliance with EU GMP and relevant national regulations.
The role sits within a mature quality organisation and offers strong scope to influence quality systems, support regulatory inspection readiness, and contribute to continuous improvement initiatives across the business.
Key Responsibilities:
QP Certification & Batch Release: Act as the named Qualified Person responsible for batch certification and release of medicinal products in accordance with applicable legislation and EU GMP requirements.
Manufacturing Oversight: Monitor GMP and dossier-compliant manufacturing and testing activities, ensuring alignment with regulatory and registration requirements.
Quality System Governance: Author, review, and approve Q-documents and SOPs, particularly those linked to batch review, certification, and release.
Quality Projects: Lead and support cross-functional QA projects and contribute to continuous improvement of the site’s quality management system.
Deviation & CAPA Oversight: Review, assess, and approve deviations, OOS/OOT events, complaints, change controls, product quality reviews (PQRs), and CAPAs.
Audit & Inspection Readiness: Support preparation, hosting, and follow-up of regulatory inspections, internal audits, and customer audits.
Supplier Management: Conduct or participate in supplier and service provider audits to ensure continued compliance and quality standards.
Qualifications & Experience:
QP Eligibility: Licensed pharmacist (or equivalent) meeting legal requirements to act as a Qualified Person in accordance with relevant national pharmaceutical legislation.
Industry Experience: Several years’ experience in the pharmaceutical industry, with strong understanding of manufacturing and QC testing processes for medicinal products.
Regulatory Knowledge: Confident application of GMP standards and pharmaceutical regulations within a regulated manufacturing environment.
Systems & Tools: Strong working knowledge of SAP and advanced proficiency in MS Excel.
Stakeholder Skills: High social competence with a collaborative mindset and the ability to operate cross-functionally.
Work Style: Able to work independently with high accountability, sound judgement, and attention to detail.
Languages: Fluent German and strong English communication skills (written and spoken).
Why Join Us?
This is an opportunity to step into a highly visible and essential quality role within an international pharmaceutical organisation. You’ll contribute directly to patient safety and product quality while operating in a structured, high-compliance environment with genuine scope to influence quality culture and standards.