QA Scientist for Batch Release - Cerdanyola del Vallès, España - Kymos

Descripción

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.