QA Scientist for Batch Release

hace 8 meses


España Kymos A tiempo completo

The QA Scientist will be assigned the following responsibilities:

- Be involved in the revision of manufacturing batch records and packaging batch records and other batch review documents of pharmaceutical products to be released.
- Participate in the certification process of batches susceptible to be released to the market or for clinical trials.
- Review of Quality/Technical Agreements between the company and manufacturers and marketing authorisatio holders, especially with regard to batch certification activities.
- Review and approve the documentation involved in the activity of the company: CoA, Site Master File, SOPs, product specifications.
- Collaborate and participate in the revision of audit reports carried out by third-parties to the manufacturers of pharmaceutical products to be released.
- Collaborate in audits carried out by our clients and give support in the Inspections of regulatory authorities.
- Participate in the implementation and improvement of the quality system of the company.
- A high level of English, both written and spoken is required for this position.



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