We are now recruiting for a QA Expert for the microbiology department to be responsible for all relevant microbiological quality assurance aspects for the manufacturing and release of drug products.
* Support microbiological monitoring of the environment in non-sterile production facilities including water, detergents & disinfectants in time and in accordance with cGMP rules, QMs and SOPs.
* planning of activities, evaluation and interpretation of the documentation and reports
* investigation of deviations,
* training of production personnel with regard to hygiene
* Supporting the analysis of the results of environmental monitoring,
* summarising of the results in periodic reports.
* Supporting the qualification/validation of clean rooms and equipment.
* qualification/validation of protocols and reports
* trouble shooting and approval of deviation reports,
* Point of contact for operators, manufacturing personnel, process experts/facilitators,
* Release of drug products, starting materials and utilities/water,
* Responsibility “critical” and “non-critical” microbiological deviations and approval of the respective microbiological risk assessment
* Ensure correct and timely preparation and dispatch of analysis certificates
* Participating in the preparation of audits and government inspections (e.g., assisting with the preparation of presentations, trends, evaluations),
* answering queries and providing information during inspections
* Writing/Review/approval of all relevant SOP’s
* Providing biological and microbiological services and QA support for global functions
* Organization, performance and coordination of training in the field of quality assurance
Required experience and skills:
Education: (Technical) University/academy degree in general or medical microbiology, biochemistry, pharmacy or equivalent.
Languages: German: fluently spoken/written; English: fluently spoken/written
Biological/microbiological analytics or diagnostics including growth properties of micro-organisms and culture media preparation; quality control/ assurance in pharmaceutical industry or biotechnology, especially with regard to environmental monitoring and cleanliness zones
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.