Description:
- Support in the establishment and maintenance of the Quality System
- Preparation, issuance and review of batch documentation
- Issuance and control of control copies for documentation
- Issuance of labels of batches, equipment and others
- Archive and scan of Quality System documentation
- Support in the management and follow-up of metrics (KPIs) of the Quality System such as incidents/deviations, risk assessment, out of specifications (OOS), CAPAs, among others.
- Support the Supplier’s Evaluation System
- Support in training
- Support in audits
- Support in the management of equipment
Requirements:
- Quality Assurance and Quality Control knowledge
- GMP/GLP knowledge
- CSV knowledge
- Analytical, problem-solving, and decision-making skills
- Time efficiency
- Team working skills
- Goal orientated
- Attention to detail
For more information or if you would like to apply for the offer, please contact egil@taav.com
About TAAV:
TAAV Biomanufacturing Solutions, SLU (TAAV), a wholly owned subsidiary of Asklepios Biopharmaceuticals (AskBio) and Bayer AG, manufactures enzymatic DNA for the production of recombinant adeno-associated viruses (rAAVs) used in gene therapies.
This synthetic material, called neDNA™, is manufactured in a biotechnological process following Good Manufacturing Practice (GMP) for clinical and commercial applications of DNA in rAAV therapeutic vectors.
neDNA™ is an alternative to the plasmid DNA commonly used in the manufacture of rAAVs. Its use can significantly shorten manufacturing lead times and facilitate faster production of rAAVs with a higher safety profile by eliminating residual bacterial sequences of plasmid DNA in the rAAV product.
TAAV was founded in 2019 and became 100% owned by AskBio in 2022. The company’s headquarters, manufacturing facilities and laboratories are located in San Sebastian, Spain.