Dr. Marcus Wernitz Email & Phone Number

Eriskirch, Bw, De

Ravensburg, Baden-Württemberg, Germany

Team Leader for the Change Control Customer Communication, interfacing between my company and the customers' Quality Assurance department, including the 20 biggest pharmaceutical companies in the world, taking care of their Block Busters and Orphan Drugs. As Change Control is an important part of the Quality Assurance and has a major impact on the successful and timely implementation of a Change. Each of my team members is responsible for a multi-b-/million business in our company and… Show more Team Leader for the Change Control Customer Communication, interfacing between my company and the customers' Quality Assurance department, including the 20 biggest pharmaceutical companies in the world, taking care of their Block Busters and Orphan Drugs. As Change Control is an important part of the Quality Assurance and has a major impact on the successful and timely implementation of a Change. Each of my team members is responsible for a multi-b-/million business in our company and multi-billion business at our customers. Together we are taking responsibilities for each patient using a product made at Vetter. I also participate in FDA and Customer Audits for QA-Change Control( Change Control as per EU-GMP Guide Annex 15, 21 CFR § 210/211 and ICH guidelines Q8/9/10).Taking care of escalated issues with the chance of compromising production, thus,market supply, I can use my problem-solving skills in a gMP- and filing-dominated , pharmaceutical environment and build on long-lasting customer relationships and emphatic relationship-creation skills. Show less

Succesfully leading a team of multi-international specialists covering the complete Abbott Molecular Diagnostic product palette.Supporting internal and external customers, including distrubutors.Responsible for the in-house training centre for customer and colleague and distributor training, including training scheduling.Participating in various audits as subject matter expert for complaint handling.Responsible for complaint documentation and handling for Europe, Middle East… Show more Succesfully leading a team of multi-international specialists covering the complete Abbott Molecular Diagnostic product palette.Supporting internal and external customers, including distrubutors.Responsible for the in-house training centre for customer and colleague and distributor training, including training scheduling.Participating in various audits as subject matter expert for complaint handling.Responsible for complaint documentation and handling for Europe, Middle East, Africa and India supporting colleagues and distributors.Setting up hotline in India. Show less

Technical Support for customers, 2nd level support and training for realtime assays and instrumentation (infectious diseases, like HIV, HCV, CT/NG, HBV, HPV), including nucleic acid extractors, FISH probes (oncolgy, praenatal diagnostis) and assays and DNA sequencer based assays. Coordination of service visits, Cmplaint documentation in a medical decive quality assurance environment.Exended experience in qPCR/rt-PCR, New experiences with quality assurance /… Show more Technical Support for customers, 2nd level support and training for realtime assays and instrumentation (infectious diseases, like HIV, HCV, CT/NG, HBV, HPV), including nucleic acid extractors, FISH probes (oncolgy, praenatal diagnostis) and assays and DNA sequencer based assays. Coordination of service visits, Cmplaint documentation in a medical decive quality assurance environment.Exended experience in qPCR/rt-PCR, New experiences with quality assurance / compliance.Inter-departemental process coordination for Europe/Middle East-/South Africa-wide instrument repair service and field service engineer visits. Complaint handling documentation in an FDA-regeulated molecular diagnostics environment. Siemens HiPath admininistration. Show less

Amsterdam-Zuidoost, North Holland, Netherlands

Ph.D., 2004, Universität KonstanzPlanning and Set-up Safety-level2 laboratory including all infrastructure and instruments and establishing numerous molecular biological methods. Knowledge transfer and method development in (plant-pathology) molecular biolgy.

Diplombiologe & Dr. Rer. Nat.

Abitur