GMP and Quality Consultant
- Verfügbarkeit einsehen
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- auf Anfrage
- 4202 Duggingen
- Umkreis (bis 200 km)
- de | en | hr
- 20.11.2024
Kurzvorstellung
Very broad experience in Pharma GMP and regulatory requirements, QA and QM.
Qualifikationen
Projekt‐ & Berufserfahrung
6/2023 – 11/2024
TätigkeitsbeschreibungConstruction and Pharma fit-out (cleanroom, laboratory, HVAC and media) of a new manufacturing facility for glass ampoules and vials: Deputy Project Manager Construction workstream, Technical and GMP Consultant, creation of User Requirement Specifications, technical Quality Assurance during Concept/ Basic / Detail Design phases, execution of Design Qualification, tendering and selection of General Contractor for Pharma fit-out, evaluation of change requests, coordination and evaluation of IQ and OQ activities performed by General Contractor
Eingesetzte QualifikationenCompliance Manager, Good Manufacturing Practices, Pharma / Kosmetik, Qualitätsmanager, Reinraum, Technisches Projektmanagement
9/2022 – 5/2023
Tätigkeitsbeschreibung
• Building up a new division for “Qualification, Validation & GMP Compliance Consulting” Services
• Acquisition of new customers and projects
• Requirements Engineering (URS) for a new Pharma glass manufacturing facility
• Requirements Engineering (URS) for a GMP upgrade project of a cold storage warehouse
Akquise / Kontakt, Good Manufacturing Practices, Ingenieurwissenschaft, Kundendienst, Mehrprojektmanagement, Pharma / Kosmetik, Projekt-Qualitätssicherung, Projektleitung / Teamleitung, Projektmanagement, Qualitätsmanagement (allg.), Reinraum, Requirement Analyse
5/2014 – 8/2022
Tätigkeitsbeschreibung
Strategy, Governance and Global Oversight – Global Analytical Specifications and Methods Management
• Global Quality Project Lead
• Lead and drive Continuous Improvement / Agile Projects in collaboration
with the Global QC Network
• Identify new Regulatory and Pharmacopoeia requirements, provide
guidance to the Global QC Network regarding Compliance and Implementation
Good Manufacturing Practices, Pharma / Kosmetik, Pharmazie, Projekt-Qualitätssicherung, Projektleitung / Teamleitung, Projektmanagement, Qualitätsdokumentation, Qualitätskostenrechnung, Qualitätslenkung, Qualitätsmanagement (allg.), Qualitätsplanung, Qualitätsrichtlinien, Risikomanagement
2/2011 – 4/2014
Tätigkeitsbeschreibung
End-to-end Quality Responsible for the Small Molecules Commercial Products assigned:
• Quality Single Point of Contact in the Supply Chain Product Teams and the
Quality Organization
• Drive and provide direction in decision making for Quality related issues
• Make Quality Product related decisions in collaboration with the appropriate Subject Matter Experts in different areas
• Provide overall assessment of the Product Quality Performance
Risikomanagement, Qualitätsplanung, Good Manufacturing Practices, Product Owner, Projektleitung / Teamleitung, Projektmanagement, Qualitätslenkung, Qualitätsmanagement (allg.), Qualitätsrichtlinien
12/2009 – 1/2011
Tätigkeitsbeschreibung
Responsible for all aspects of Quality Assurance for assigned Marketed and Investigational Medicinal Products
• Preparation of product related Health Authority Inspections
• Negotiation of „Technical Quality Agreements“
• GMP compliance audits of contract manufacturers
• Review and approval of protocols and reports
• Review of Regulatory Documentation
• Release of API, Pharmaceutical Dosage Forms and Finished Products
according to Swiss Regulations (Deputy to the Qualified Person “Fachtechnisch Verantwortliche Person”)
Forschung & Entwicklung, Pharma / Kosmetik, Qualitätsprüfung, Qualitätsverfahrensanweisung, Auditor, Good Manufacturing Practices, Qualitätsdokumentation, Qualitätsrichtlinien, Qualitätssicherungssysteme
8/2009 – 11/2009
TätigkeitsbeschreibungGMP Compliance Consulting for a Medical Device customer, Design Transfer
Eingesetzte QualifikationenProjektleitung / Teamleitung, Qualitätsmanagement (allg.), Qualitätsrichtlinien, DIN EN ISO 13485, Good Manufacturing Practices, Kundendienst, Projektmanagement
7/2007 – 5/2009
Tätigkeitsbeschreibung
• Representation of TRD Global Quality in Technical Development project teams
• Coordination and consolidation of project related QA activities in a global matrix organization and with external collaboration partners
• Risk management with regards to quality aspects in development projects
• Guidance regarding Quality aspects to the project teams
• Preparation of project related Health Authority Inspections (i.e. US FDA
„Pre Approval Inspections“)
• Negotiation of „Technical Quality Agreements“ with external collaborations
Projektleitung / Teamleitung, Projektmanagement, Auditor, Forschung & Entwicklung, Good Manufacturing Practices, Markteintrittsstrategien, Qualitätslenkung, Qualitätsmanagement (allg.), Qualitätsrichtlinien, Risikomanagement
7/2004 – 6/2007
Tätigkeitsbeschreibung
• Performance of global GMP Audits with Contract Manufacturers / Testing Labs and Suppliers and internal GMP Audits (Lead Auditor)
• Preparation of project related Health Authority Inspections (i.e. US FDA „Pre Approval Inspections“)
• Preparation of Technical Development Departments for general GMP Inspections and Audits (incl. inspection training)
Auditor, Forschung & Entwicklung, Pharma / Kosmetik, Pharmazie, Qualitätsmanagement (allg.), Qualitätsprüfung, Qualitätsrichtlinien, Qualitätssicherungssysteme, Risikomanagement
10/2000 – 6/2004
Tätigkeitsbeschreibung
• Project Leader in various qualification and validation projects for different Pharmaceutical companies, e.g. qualification of upgraded GMP production facility, cleanrooms, manufacturing equipment, water for injection system, clean steam system (URS, Quality Risk Analysis (FMEA), DQ, IQ, OQ, PQ)
• GMP compliance consulting, audits
FMEA (Failure Mode and Effects Analysis), Auditor, Fehlermöglichkeits- und -einflussanalyse (FMEA), Good Manufacturing Practices, Projektleitung / Teamleitung, Projektmanagement, Qualitätsdokumentation, Qualitätsmanagement (allg.), Qualitätsrichtlinien, Qualitätssicherungssysteme, Qualitätsverfahrensanweisung
1/1994 – 9/2000
Tätigkeitsbeschreibung
• Creation of Validation Master Plan and concepts and SOPs for equipment qualification, cleaning and process validation in the Packaging department
• Qualification and Validation protocols and reports
• Training of personnel
• System owner of purified water system
Ingenieurwissenschaft, Qualitätsmanagement (allg.), Good Manufacturing Practices, Prozessvalidierung
Ausbildung
Hochschule Albstadt-Sigmaringen
Sigmaringen
Über mich
Experienced in Quality Assurance and Quality Management (Product Quality responsible for marketed and investigational products, global management of analytical specifications and methods, GMP auditing, inspection preparation, release of active pharmaceutical ingredients, pharmaceutical dosage forms and finished products, risk management, GMP consulting, qualification and validation, stability, regulatory requirements (e.g. US FDA, EU, ANVISA), pharmacopoeia requirements, project management).
Highly committed, flexible and adaptable, focused on business needs, quality and solution excellence.
Looking for freelance assignments in GMP / Quality (e.g. GMP Auditor, GMP Consulting, Training, Routine QA and QM Support, Quality Projects).
Weitere Kenntnisse
Persönliche Daten
- Deutsch (Muttersprache)
- Englisch (Fließend)
- Kroatisch (Gut)
- Französisch (Grundkenntnisse)
- Europäische Union
- Schweiz
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