gempex GmbH

Consultant

• CSV compliance consulting (including ERP, databases, and automation systems such as MES, PLS and PLC)
• Preparation for and support during regulatory inspections
• Consulting and development of IT validation concepts in accordance with GAMP 5
• Conducting training, mentoring, and contributing to the development of internal tools
• Active involvement in professional associations, including presentations and expert articles
• Business development and client relationship management within consulting projects

Principal Consultant – IT Validation, Pharmaceutical GMP Environment

QA Engineer

• Selbstständige Bearbeitung von Kundenprojekten im Bereich QA/QM/RA
• Beratung und operative Unterstützung zu GxP-Themen
• Aufbau und Optimierung von GxP-Qualitätssystemen
• Begleitung von Inspektionen und Durchführung von Audits
• Beratung zu Consumer Health Produkten
• Unterstützung bei Abgrenzungsfragen
• Bearbeiten und Einreichen von Zulassungsgesuchen
• Life Cycle Management (Variations, Renewals)
• Mithilfe beim Ausbau und Weiterentwicklung der Dienstleistungen

Consultant Qualitätssicherung QA/RA

Compliance

• Eigenverantwortliche Projektplanung und -umsetzung im Bereich Pharma & Life Sciences
• Termin- und Qualitätsverantwortung in den Projekten
• Direkte Ansprechperson für Projektfragen
• Erstellung relevanter GMP-Dokumente (z. B. Testprotokolle, Technische Changes, Qualifizierungsberichte) in Abstimmung mit dem Kunden
• Bewertung von Änderungen unter Berücksichtigung geltender Vorgaben und Standards
• Schnittstellenkommunikation mit QA, QC, Produktion sowie ggf. Planern und Lieferanten

Senior Projekt Ingenieur – GMP Compliance, Life Sciences

• Drafting GMP-compliant SOPs and risk analyses in German and English
• Participating in the qualification of pharmaceutical equipment and systems and preparing related documentation
• Reviewing equipment and processes for GMP compliance
• Coordinating and organizing maintenance, calibration and qualification activities
• Checking technical documentation for changes and deviations
• Supporting change control and deviation management

GMP Consultant, Entry-level applicants welcome

• General GMP compliance and strategic consulting
• Preparation for and support during regulatory inspections
• Conducting audits, gap analyses, and due diligence studies
• Advising on supply chain strategies (MAH/MAA topics — Marketing Authorisation Holder/Marketing Authorisation Applications)
• Providing training, mentoring, and workshops
• Contributing to the development of internal tools and work aids
• Active participation in professional associations, delivering presentations and technical contributions
• Business development and ongoing client relationship management in consulting projects

Principal Consultant – Quality Assurance, Pharmaceutical (GMP)

• Selbstständige Umsetzung von QM-Projekten von der Projektinitialisierung bis zur -abwicklung
• Planung und Durchführung von Projektmeilensteinen
• Qualifizierung von pharmazeutischen Produktionsanlagen und Geräten
• Analyse und Bewertung pharmazeutischer Qualitätssicherungssysteme
• Validierung und Optimierung von Herstellungsprozessen
• Qualifizierte Betreuung der Projektkunden in allen GMP-Fragestellungen
• Erarbeitung von GMP-gerechter Dokumentation (SOP´s, Risikoanalysen) in Deutsch und Englisch

QA Manager – Consultant GMP-Compliance, Pharma/Biotech/Healthcare

• Lead Quality & Regulatory compliance consulting projects in the medical technology sector, with a focus on medical device software
• Prepare risk analyses and technical documentation
• Implement processes within the quality management system
• Conduct gap analyses to prepare for audits (US FDA & Notified Bodies)
• Provide advice on post-market surveillance in accordance with international regulations

Senior Consultant, Compliance Medical Devices

• Independent management of client projects in the areas of QA/QM/RA
• Consultancy and operational support on GxP topics
• Establishment and optimization of GxP quality systems
• Support during inspections and conduct of audits
• Consulting on consumer health products
• Support with product classification and delineation questions
• Preparation and submission of regulatory/marketing authorization applications
• Life cycle management (variations, renewals)
• Assistance in expanding and further developing services

Consultant Quality Assurance (QA/RA)

• Independently plan and execute projects in the Pharma & Life Sciences sector
• Responsible for project schedules and quality
• Primary point of contact for project-related questions
• Prepare relevant GMP documentation (e.g., test protocols, technical change documents, qualification reports) in coordination with the client
• Assess changes in accordance with applicable regulations and standards
• Coordinate with QA, QC, production, and, where applicable, planners and suppliers

Senior Project Engineer – GMP Compliance, Life Sciences

• Preparation of GMP-compliant SOPs and risk analyses in German and English
• Support in the qualification of pharmaceutical equipment and systems and their documentation
• Review of facilities and processes for GMP compliance
• Coordination and organization of maintenance, calibration and qualification activities
• Review of technical documentation for changes and deviations
• Support with change control and deviations

GMP Consultant – Entry-level candidates welcome

• Contribution to the development of optimized qualification and validation concepts
• Execution of qualifications for high‑tech equipment in the pharmaceutical and biopharmaceutical industry
• Participation in risk analyses
• Support in validation projects (e.g., cleaning, process, and method validations)
• Preparation of GMP‑compliant documentation, including Standard Operating Procedures (SOPs)
• Review of technical documents and drawings, as well as changes and deviations

Consultant GMP Compliance, Quality Assurance

Product Marketing

• Support qualification and validation projects at our clients
• Prepare complex documentation in German and English
• Handle deviations and quality assurance measures
• Assist in performing risk analyses

Qualification Engineer, GMP / Pharmaceutical / Life Sciences

• Advising our clients on all matters related to technical GMP compliance
• Assessing technical solutions (from simple systems to comprehensive new-build projects)
• Supporting and advising on the development of layout, cleanroom, and hygiene concepts, etc.
• Conducting gap analyses and/or audits in existing facilities
• Taking on project management responsibilities as part of GMP advisory support for new-build and/or retrofit projects
• Mentoring and supporting junior staff

Consultant, Project Manager GMP Compliance

• CSV-Compliance Beratung (u. a. ERP, Datenbanken, Automatisierungssysteme MES, PLS, SPS)
• Vorbereitung und Begleitung von Behördeninspektionen
• Beratung und Konzepterstellung für IT-Validierung nach GAMP 5
• Durchführung von Schulungen, Mentoring, Mitwirkung bei der Ausarbeitung von internen Tools
• Aktive Verbandsarbeit, Vorträge und Fachbeiträge
• Akquise und Kontaktpflege im Rahmen von Beratungsprojekten

Principal Consultant – IT-Validierung, pharmazeutisches GMP-Umfeld

• General GMP compliance and strategic consulting
• Preparation for and support during regulatory inspections
• Conducting audits, gap analyses, and due diligence assessments
• Advising on supply chain strategies (MAH and MAA topics)
• Delivering training, mentoring, and workshops
• Contributing to the development of internal tools and working materials
• Active participation in industry associations, presentations, and technical publications
• Business development and ongoing client management in consulting projects