Production & Quality Management
Team Production is responsible for manufacturing the products developed in R&D. Requirements for good manufacturing practices and product quality are defined, implemented and controlled by the Quality team in close collaboration with Production.
What does Team Production do?
- Manufacturing of enzyme products
- Transfer of manufacturing processes to external production partners
- Procurement and storage of raw materials and consumables
- Procurement and qualification of manufacturing equipment
- Support of customer audits, authority audits and third party audits
- Preparation of products for shipment
What does Team Quality do?
- Management and continuous improvement of the company-wide QM system acc. to the certified standards ISO 9001 and Good Manufacturing / Distribution Practices (GMP/GDP) for pharmaceutical excipients
- Quality assurance for all manufacturing processes (e.g. by evaluation of suitable raw materials and consumables, batch record review, etc.)
- Management of deviations and changes during manufacturing and quality control in close collaboration with the departments
- Quality control of internally and externally manufactured products acc. to specified analytical parameters and release of products before delivery to customers
- Execution of product stability studies
- Analytical method validation
- Management of customer complaints
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