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.

Quality management
  • Person responsible for regulatory compliance” for small enterprises according to Directive 2003/361/EC.

  • Selection and monitoring of external suppliers and contract manufacturers.

  • Safety Officer for Medical Devices

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.

Development

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.

Qualification

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.

Regulatory Affairs