Quality management
More than 20 years of experience in quality management in the pharmaceutical and medical device industry.
Introduction / development of QM system according to ISO 13485, ISO 9001 and FDA 21 CFR Part 820, EU-GMP guideline, FDA 21 CFR 210 & 211, 21 CFR 11.
Responsible preparation and monitoring of audits by national and international drug authorities (e.g. FDA, ANVISA), notified bodies (e.g. TGA) and customers.
External QMB/Interims QMB, also for outsourced sub-processes such as management evaluation, risk management, complaint management, internal and external audits, change control or CAPA management to relieve the quality manager of his work.
Maintenance of QM manual and complete documentation of the QM system.
Person Responsible for Regulatory Compliance (PRRC) in accordance with Article 15 MDR.
Selection and monitoring of external suppliers and contract manufacturers.
Development
More than 20 years of experience in quality management and development of sterile drugs.
Pharmaceutical and medical technology production transfer.
Formulation development, stability testing, optimization of production parameters.
Development of production processes, in particular for the manufacture of sterile products.
Product, process and recipe inventions and their patent applications.
Qualification
Over 12 years of experience as Head of Validation and Qualification.
Qualification (URS, DQ, IQ, OQ, PQ/PPQ) of clean rooms, production equipment and analytical equipment.
Validation of production processes.
Validation of cleaning procedures.
Validation of analytical methods.
Validation of computer-aided systems.
Regulatory Affairs
Profound knowledge of European and international GMP regulations and ISO standards.
Provision of non-clinical marketing authorisation documentation (CMC part) for medicinal products.
Preparation of the entire technical documentation for medical devices of all classes.
GAP analyses to assess regulatory compliance.
