Holger Lass Email and Phone Number

Responsible for “GMP-Standards” at site Elberfeld and quality assurance of “Quality Control”• Organization of the deviation and complaint management• Organization of self-inspections at site Elberfeld• General Quality Oversight (e.g. GEMBAS, inspection tours)• Support agency inspections and act as counterpart for quality related inquiries and follow-up activities resulting from audit findings• Quality assurance of quality control at site Elberfeld

Responsible for the quality assurance in quality control of site Elberfeld and C7F7 production• Qualified Person for APIs• Assess, approve or reject changes, complaints as well as qualification, validation or verification plans and records to ensure compliance within projects, manufacturing plants and quality control laboratories• Responsible for specifications of intermediates and bulk products• Apply state-of-the-art QA-principles as well as improve and maintain compliant quality standards for manufacturing of biologics (APIs, Drug Product)• Release or rejection of drug substance/drug product, bulks and intermediates to ensure consistent quality and compliance• Team member in projects with high complexity and lead projects• Support agency inspections and act as counterpart for quality related inquiries and follow-up activities resulting from audit findings

Responsible for the quality assurance in biotechnology• Qualified Person for APIs• Assess, approve or reject changes, complaints as well as qualification, validation or verification plans and records to ensure compliance within projects, biologic manufacturing plants and quality control laboratories• Responsible for specifications of intermediates and bulk products• Apply state-of-the-art QA-principles as well as improve and maintain compliant quality standards for manufacturing of biologics (APIs, Drug Product)• Release or rejection of drug substance/drug product for biologics, bulks and intermediates to ensure consistent quality and compliance• Support multidisciplinary teams in GMP relevant aspects including review and approval of documents related to qualification and validation (production and quality)• Team member in projects with high complexity and lead projects• Support agency inspections of biotech plant and act as counterpart for quality related inquiries and follow up activities resulting from audit findings

Heading Quality Control Laboratory:• Resopnsible for ensuring cGMP compliance and timely execution of analytical testing and assessment of pharmaceutical quality• Leading complex interdiciplinary project teams to solve strategic problems• Manage work activities and align resources across functional areas• Ensure compliance of quality control methods• Subject mater expert for technology transfer and comparability strategies• Staff Management inclusive Recruiting and Decruiting, Planning, Deployment, Organisation• Process improvement

Heading Site Waltrop:• Sales Planning and Business Development• Staff Management inclusive Recruiting and Decruiting, Planning, Deployment, Organisation• Organisation of Department and Working Processes• Maintenance of Quality System (GMP)• Investments • Site Management• Development and Maintenance of Health, Safety and Environment System• Representation of the Company

Heading operationsIntegration into Nuvisan Group

Department HeadTest Facility ManagerOfficer with Procurement

Department HeadTest Facility ManagerOfficer with Procurement

Officer with procurementTest Facility ManagerHead of the Department of Bioanalytics