Greater Karlsruhe Area
Assuming responsibility as qualified person according to § 14 AMG. Approval and certification of the batches in terms of conformity with the specifications of the AMG and GMP guidelines. Responsibilities include establishment of analytical methods/ Validation/ for raw material / intermediates / bulk materials / finished products, implementation of stability studies. Execution of regulatory Audits and international customers. General Laboratory Management responsibilities.
Responsibilities include Validation of analytical methods for m-RNA VAccines and maintain adequate procedures for data collecting and reporting. Participation in the creation of the analytical documents for the EMA approval.
Responsibilities include establishment of an best practise Guide for method Validation / method transfer / verification process. - Extensive experience with international customers - General Analytical Project Management responsibilities including cooperating routine operation of laboratory, coordinating Analytical Project Managment duties for a team of Analytical Project Leader. - including Reviewing / approving final validation protocols and reports. - Acting as a liaison between the laboratory and other internal departments as well as external laboratories
- Responsibilities include establishment of an overall cleaning validation master plan, analytical method development / validation / method transfer / verification process, establishment of product specific stability programs - Extensive experience with International Regulatory bodies (FDA, ANVISA, Turkey, RP Tubingen,..) and international customers - General Laboratory Management responsibilities including overseeing routine operation of laboratory, coordinating laboratory duties for a team of 10 Lab technicians. - Reviewing / approving final validation protocols and reports. - Acting as a liaison between the laboratory and other internal departments as well as external laboratories
Laboratory Manager Vitamin Mineral Supplement and Pharmaceuticals - Responsibilities include establishment of analytical method validation for raw materials / intermediates / bulk materials / finished products, implementation of stability studies. - Execution of Regulatory Audits (Swiss Medic) and international customers. -General Laboratory Management responsibilities including overseeing routine operation of laboratory, coordinating laboratory duties for a team of 35 Lab technicians.