QA Scientist for Batch Release
Location
Cerdanyola del Vallès, Barcelona | Spain
Job description
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.
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