03.06.2024 aktualisiert
100 % verfügbar
Freelance Pharmaceutical Consultant
Rüthen, Deutschland
Weltweit
Chemical EngineerSkills
HVACGood Manufacturing PracticesKommunikationsprotokolleBauleitungContent ManagementEDMSInfrastrukturLIMSLean ProzesseManagement SystemeSachgüterproduktionProjektmanagementKontrollminderndOperational Risk ManagementProzessleittechnik
Engineering Controls Compliant Concept Engineering for key workflows URS writing / review and Procurement assistance (technical comparisons) Construction Management (review design flaws for operatability) Quality by Design (QbD) – concepts of Lean Designs or 5S etc Project / Operations Risk Assessment and mitigation measures suggestions High end software projects like MES, LIMS, CMS, EDMS Strong Project Management skills to support any project
Technology Transfers Gap assessment in infrastructure (QC or Manufacturing) to support new product introduction Mitigation of identified Gaps through sound risk assessment documentation practices Qualification of plugged Gaps to meet the most stringent regulatory requirements Review of Analytical Method Validations (AMV) or Method Transfer (AMT) Protocols for GLP requirements Assess qualification and compliance status of laboratories prior to initiating AMT / AMV Write / Review Process Validation documentation to meet any regulatory standards Assess process validation efficiency for smooth commercial operations
Facility Qualification Writing or reviewing URS and supporting technical evaluation for procurement Writing and designing protocols for qualification of common Utilities (any dosage form) Writing and designing protocols for qualification of Clean Utilities (Water for Injection or Pure Steam) Writing and designing protocols for qualification of HVAC Systems (Grade A through D) Writing and designing protocols for qualification of manufacturing or filling equipment Writing and designing protocols for qualification of manufacturing or filling equipment protocols for qualification of packaging equipment Computer System Validation basis GAMP or CFR Part 11 requirements Validation of tools like MES / LIMS / Documentation management systems Risk Assessment based protocol design approach
Regulatory Knowledge about EU/US GMP guidelines Knowledge about latest Annex 1 or CFR for cGMP compliance Knowledge about GAMP and / or CFR Part 11
Technology Transfers Gap assessment in infrastructure (QC or Manufacturing) to support new product introduction Mitigation of identified Gaps through sound risk assessment documentation practices Qualification of plugged Gaps to meet the most stringent regulatory requirements Review of Analytical Method Validations (AMV) or Method Transfer (AMT) Protocols for GLP requirements Assess qualification and compliance status of laboratories prior to initiating AMT / AMV Write / Review Process Validation documentation to meet any regulatory standards Assess process validation efficiency for smooth commercial operations
Facility Qualification Writing or reviewing URS and supporting technical evaluation for procurement Writing and designing protocols for qualification of common Utilities (any dosage form) Writing and designing protocols for qualification of Clean Utilities (Water for Injection or Pure Steam) Writing and designing protocols for qualification of HVAC Systems (Grade A through D) Writing and designing protocols for qualification of manufacturing or filling equipment Writing and designing protocols for qualification of manufacturing or filling equipment protocols for qualification of packaging equipment Computer System Validation basis GAMP or CFR Part 11 requirements Validation of tools like MES / LIMS / Documentation management systems Risk Assessment based protocol design approach
Regulatory Knowledge about EU/US GMP guidelines Knowledge about latest Annex 1 or CFR for cGMP compliance Knowledge about GAMP and / or CFR Part 11
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2024
Sprachen
DeutschgutEnglischverhandlungssicher