Technical Manager and Head of Quality Assurance and Quality Control
- Maintaining the quality system under GMP and ISO9001 certification for the manufacture of active substances of biological origin and ensuring compliance.
- Review and approve all standardised quality related documents.
- Ensuring proper preservation and custody of standardised documentation.
- Review the complete manufacture of active substance batches and Quality Control laboratory records to approve or reject active substance batches prior to distribution.
- Ensure that each batch of active substance has been manufactured and controlled according to the legislation in force, in compliance with the requirements of its authorisation and with the GMP.
- Ensure the proper management of the quality control laboratory.
- Establish, maintain and manage the Validation, Qualification and Calibration Plan of the plant.
- Manage the quality control and quality assurance work team.
- Experience and training required to assume the position of Technical Manager (Royal Decree 824/2010, Art. 17)
- High level of spoken and written English.
Quality Control Technician
- To carry out quality controls of raw materials, intermediate products and final products.
- To manage the storage and stock of materials and reagents.
- Manage equipment calibrations and qualifications.
- Managing stability tests.
- Review of deviations, change controls, complaints and other quality events.
- Bachelor’s degree in biology, preferably in pharmacy.
- Extensive knowledge of the English language.
- Extensive experience in Molecular Biology techniques and protein analysis, especially PCR, qPCR, Western Blot, Elisa, etc.
- Experience in Quality areas under Good Manufacturing Practices. Management of reagents and materials. Calibration and equipment qualification management.
- Handling of cell cultures and viruses (non-pathogenic) under sterile conditions.