Qualified Person
vor 1 Monat
CONTRACT ASSIGNMENT ONLY
6 month contract - potential to extend
Must be onsite in Stuttgart region
Competitive hourly rate available
- Approval of medicinal products and investigational medicinal products as a qualified person in accordance with Section 14 AMG Paragraph 1
- Release of bulk goods from external contract manufacturing companies for further processing
- Ensuring compliance and implementation of requirements from the Medicines Act, AMWHV and EC GMP guidelines
- Personal responsibility for the market release of medicines
- Supporting the head of quality control in pharmaceutical law issues as an expert person. § 14 AMG paragraph 1
- Ensuring the proper handling, documentation and processing of deviations, cause analyzes and change control processes
- Contact person for complaints from authorities and participation in the investigation of drug complaints
- Ensuring that approved medicinal products are manufactured and tested in accordance with the requirements laid down in the approval
- Review and approval of change control procedures
- Reviewing and approving PQRs (Periodical Quality Reviews of medicinal products) in coordination with the respective releasing pharmaceutical manufacturers
- Ensuring proper drug production and maintenance of the quality management system in compliance with all relevant regulations
- Organization and continuous improvement of the quality management system, taking business aspects into account
- Contact person representing the surveillance authorities
- Ensure compliance and monitoring of all GMP and legal quality requirements for all product categories
- Checking pharmaceutical contracts: e.g. B. Quality agreements and responsibility delimitation contracts
- Technical collaboration in the new and further development of drugs and formulations
- Ensuring stability tests and monitoring product stability
Reach out to daniel.jeffery@biotalent.com for more information.
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