Vast Experience with biochemical analytics like HPLC, RIA, ELISA
Many years of QP/QS-experience in the pharmaceutical industry including aseptic and sterile production
Vast Experience with different operating and evaluation systems
Hands-On Mentality
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Our content and services may vary by location.
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Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Study of Biology incl. Biochemistry & Microbiology
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Quality Assurance, Microbiology, APIs, final drugs, Monoclonal antibodies, Audits, Sterile Production, GMP, Deviation, CAPA, HPLC, RIA, ELISA, BioTech, Pharma
Key-Facts
Extract from previous activities
BioTech Company, Germany
Interim Head of QC, Microbiology & Animal Tests, Qualified Person
Microbiology, animal experiments (insulin) and chemical analyses for liquid, solid & semisolid drugs
Responsible QP for analytics, biology and QC, batch releases
Interim Head of QC / Qualified Person, budget planning and controlling
Documentation acc to GMP/PIC
Internal Audits and Audits of suppliers
Back up support to the RP pharmacovigilance
Pharmaceutical Company, Germany
QA Consultant
QA BRR of biotechnological production of monoclonal antibodies (mammalian cells/bacteria)
Work for an international leader in the production of APIs and final products of biologics and biosimilars at different sites in the EU
BioTech Company, Germany
Manager QA and Qualified Person
Interim Head of quality assurance department for a pharmaceutical site producing drugs and packaging vaccines for veterinary use
Quality Management System: SOPs for two sites
Technical pharmaceutical contracts for sales and distribution local and EU and export to countries outside EU and contracts for transportation including contract manufacturing
Qualification of storage facilities
Compliance of batches to MA
cGMP and GDP
Change control, PQR, control and CAPA of GMP-deviations
Internal and external audits, training
Final QP-release
QA-representative for inspections by the German Authorities
Pharmaceutical Company, Germany
QA Consultant - Microbiology
QA Management
Reviews of PQRs of APIs and final drugs
Complaints and GMP training of personnel
QP-Support for biotech. products
GDP, imports
Implement, maintain, and oversee environmental programming
Pharmaceutical Company, Germany
Qualified Person
QP for a pharmaceutical site producing drugs and vaccines for veterinary use, including final QP-release
Pharmaceutical Company, Germany
Interim Head of QC / Qualified Person
Design, realization and responsible leader of microbiological lab
Audits (GMP, FDA)
Implementation of a QS-System, documentation in German, and English
Leading a team of 13 staff members, budget planning and controlling
Pharmaceutical Company, Germany
Scientist Neuropsychoendocrinology
Research projects: work with rats as animal model, endocrinological feedback system and changes of adrenergic receptors in the brain
Modern methods of chemical and biochem. analytics HPLC, RIA, ELISA