Dr. Stefan Padlesak QP

tasks: release of batches, Qualified Person, batch records, deviations, CAPAs, Changes, complaints, SOPs, audits of manufacturer and labs, review of quality agreements, participation in customer- and health authority inspections, self-inspections, training of employees, head of the QA department, leading and development of external and internal personnel, 6 direct reports, ensuring quality systems products: investigational medicinal products (IMP), comparators

tasks: release of batches, Qualified Person, batch records, deviations, OOS, SOPs, audits of manufacturer and labs, review of quality agreements, participation in customer- and health authority inspections products: investigational medicinal products (IMP)

Qualified Person tasks: author and reviewer of different GMP documents, for example: risk analysis, SOPs, deviations, OOS, change controls, APR and PQR, batch records, release of batches, Qualified Person, review of quality agreements, participation in customer- and health authority inspections products: antibiotics, sterile filled powders, tablets

author and reviewer of different GMP documents (e.g.: risk analysis, SOPs, deviations, change controls, APR and PQR, batch records)releasing of batches Qualified Person

leading of department Analytical Science and Technology organization and execution of method validations internal and with external labs qualification of analytical equipment managing reference standards insure pharmacopeia compliance

leading of department Analytical Science and Technology organization and execution of method validations internal and with external labs qualification of analytical equipment managing reference standards insure pharmacopeia compliance

leading of department Analytical Services organization and execution of method validations internal and with external labs qualification of analytical equipment

leading of validation department validation management, organization and execution of cleaning, process validations and filter validation

validation management, organization and execution of cleaning, process and filter validations

unit process development department, development of a operation for the eless deposition of platinum, working in teams with other departments

pharmacy and quality management training for Qualified Person according to AMBO 2009 §7 (4)

excellent success