- 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 evaluation of deviations, OOS/OOT, complaints, CAPA and Change Controls of pharmaceutical products to be released ensuring the application of GMPs and according to the marketing authorisation or clinical trail authorisation.
- 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 andapprove 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.
- The candidate should have knowledge in Pharmaceutical Analysis, Quality Control, Manufacturing and Quality Assurance following the requirements of Good Manufacturing Practices.
- A high level of English, both written and spoken is required for this position.
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QA Scientist for Batch Release - España - Kymos Group
Descripción
We are an innovative and fast-growing CRO offering you the opportunity to develop your career in an excellent working environment. Kymos Group is a scientific-technical services company directed to companies of the chemical-pharmaceutical and veterinary sector.
KYMOS offers a wide range of analytical services in Medicinal Chemistry to optimize the research, the development and the quality control for innovative, generic and biological drug substances and drug products from the preclinical stage to market.
KYMOS also has an extensive experience in developing and validating bioanalytical methods and sample analysis in any biological matrix using the latest technology. Mass spectrometry and immunology laboratories are available to carry out small molecule and biologic projects.
KYMOS is also an international group, Kymos Group, with sites in Italy, PHARMAPROGRESS and in Germany, PROLYTIC.
The QA Scientist will be assigned the following responsibilities:
We are looking for a candidate with a Life Sciences Degree, preferably with Pharmacy Degree, and with 2 years of experience in Quality Control or Manufacturing activities in Quality Assurance or Quality Control or Manufacturing in the Pharmaceutical Industry. Experience on Biologicals will be highly valued.
Usuarios de profesión QA Scientist for Batch Release en Madrid
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