25.11.2025 aktualisiert
60 % verfügbar
Senior Pharmaceutical Consultant - GMP
Kelkheim, Deutschland
Weltweit
PharmacistÜber mich
Neues zu lernen motiviert mich - Ich verfüge über eine schnelle Auffassungsgabe und arbeite mich zügig in neue Aufgaben oder Themen ein. Ich erledige meine Aufgaben effizient, sorgfältig und verantwortungsbewusst.
Skills
Good Manufacturing PracticesChange ControlChange ManagementComplianceFmeaHygieneSachgüterproduktionProzessleittechnikQualitätsmanagementRisikoanalyseTechnologietransferBeurteilungen DurchführenVerpackung und KennzeichnungFertigungsprozesseTeam ManagementRegulatory AffairsReinigungsvalidierungRisikomanagementPharmaproduktion
GMP Compliance and Quality Systems
Comprehensive expertise in Good Manufacturing Practice implementation, quality system upgrades, and regulatory compliance for pharmaceutical manufacturing
Process Validation and Risk Management
Advanced knowledge in process validation methodologies, risk analysis using FMEA, and continued process verification for pharmaceutical operations
Regulatory Affairs and Documentation
Specialized skills in regulatory support, creation of compliance documentation, and handling agency communications for pharmaceutical submissions
Technology Transfer Management
Expertise in developing transfer strategies, conducting gap assessments, and managing pharmaceutical technology transfers
Change Management and Deviation Handling
Proficient in implementing change control processes and managing deviations in pharmaceutical manufacturing environments
Training and Staff Development
Experience in training manufacturing staff on GMP basics, hygiene protocols, and manufacturing technologies
Manufacturing Operations Management
Leadership experience as Head of Manufacturing with responsibility for solid dosage form production and packaging operations
Cleaning Validation and Equipment Qualification
Specialized knowledge in cleaning validation concepts, qualification projects, and equipment integration
Comprehensive expertise in Good Manufacturing Practice implementation, quality system upgrades, and regulatory compliance for pharmaceutical manufacturing
Process Validation and Risk Management
Advanced knowledge in process validation methodologies, risk analysis using FMEA, and continued process verification for pharmaceutical operations
Regulatory Affairs and Documentation
Specialized skills in regulatory support, creation of compliance documentation, and handling agency communications for pharmaceutical submissions
Technology Transfer Management
Expertise in developing transfer strategies, conducting gap assessments, and managing pharmaceutical technology transfers
Change Management and Deviation Handling
Proficient in implementing change control processes and managing deviations in pharmaceutical manufacturing environments
Training and Staff Development
Experience in training manufacturing staff on GMP basics, hygiene protocols, and manufacturing technologies
Manufacturing Operations Management
Leadership experience as Head of Manufacturing with responsibility for solid dosage form production and packaging operations
Cleaning Validation and Equipment Qualification
Specialized knowledge in cleaning validation concepts, qualification projects, and equipment integration
Sprachen
DeutschMutterspracheEnglischverhandlungssicherFranzösischGrundkenntnisse
Projekthistorie
Providing regulatory support, process validation, transfer projects, and life cycle management services for pharmaceutical companies in Pharma, API, and Biotech sectors
Managed GMP upgrade projects, implemented QA systems, conducted process validation, and provided training for pharmaceutical and API manufacturing companies
CMO for manufacturing and packaging of solid dosage forms with full operational responsibility