We are searching for a quality assurance expert with distribution and supply chain expertise to support processes and procedures, tasks, responsibilities and projects
Your tasks: Ensure compliance with GMP and regulatory requirements (including record management) and continuous improvement of quality relevant processes within area of responsibility. Maintain current knowledge of regulatory and legislative requirements and trends to ensure that the expert advice and appropriate technical support on all quality related distribution activities is provided. Ensure that all aspects of handling and distribution of pharmaceutical products comply with the Corporate Quality Manual, regulatory and legislative requirements. Downloading of temperature data loggers received from external partners and evaluation of results.
Perform GMP inspections (self-inspections and inspections of third parties, e.g. carriers and warehouses) and prepare, support Health Authority inspections Support quality assessments and recalls by delivering lot tracings. Deviation and complaint handling within global Supply Chain units Support the “return process” including QA evaluation according to PhSC procedure. Review documents for correctness and completeness and if necessary request missing documents
Support the maintenance and administration of the Operational Quality Manual
Decide on release for further shipments stored in Pharma Supply Chain warehouse by checking the completeness and the correctness of the batch documentation. Support revision and write QA agreements with warehouse and transportation service providers. Requirements:
Education: Degree in life sciences, preferably in pharmacy or chemistry or equivalent Languages: Good English (spoken and written). German desired. Experience: 4- 5 years experience in pharmaceutical Quality Assurance or in pharmaceutical production, quality control or supply chain. GMP knowledge. Pharmaceutical Quality Assurance / GMP background, Leadership. Desired experience in Supply Chain
Michael Bailey International is acting as an Employment Business in relation to this vacancy.