Qa Scientist For Batch Release

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 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 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. 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. 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.