Quality Assurance Manager- (ISMIR)-Master degree in Biology Biomedical Sciences or similar (ISMIR)

Master degree in Biology Biomedical Sciences or similar

The Fundación offers a contract for the position of "Quality Assurance Manager", who will also assume the capacities of the Deputy Technical Manager in the Advanced Therapy Medicines Production Unit of the Paediatric Haematology-Oncology Service of the Hospital La Paz.
It is necessary that the person has the ability to work in multidisciplinary teams, knowledge of Good Manufacturing Practice (GMP/GMP) and ideally GMP/GMP-ATMPs (Advanced Therapy Medicines).
The candidate should have experience in the following functions:
-  Execution of the implementation of the Quality Assurance system necessary to guarantee the quality, safety, efficacy and traceability of the manufactured products

.-  Updating the register of documents in force (and external documentation).
 .-Review of all documentation before its entry into force, checking that it complies with the requirements of the NCF-ATMPs.
 .-Preparation of documentation relating to staff training, posts, equipment, incidents, purchase management, complaints, withdrawals, etc.).
.- Documentary control: filing of electronic informative copies, of the external distribution of documentation and withdrawal of obsolete copies, filing of the originals of the documentation in force, management of the process of modification and changes to documents, registration of signatures of authorised personnel, for the different Areas of the Quality System, etc.
 .-Managing and guaranteeing the implementation of the incident monitoring system.
 .-Manage and guarantee the implementation of the change control system.
 .-Manage and guarantee the implementation of the risk management system.
.- Manage the selection and approval of suppliers so that they comply with the requirements demanded.
 .-Review and control of the documentation associated with the maintenance, calibration and qualification of up-MTA equipment and installations.
 .-Preparation of the annual plans defined in the Quality System (Annual Training Plan, Annual Internal Audits Plan, Equipment Validation and Qualification Plan, etc.), as well as monitoring of their execution and evaluation/assessment after their completion.

- He/she will perform the tasks of Deputy Technical Manager in the absence of the incumbent whose main function is to verify and certify that each batch produced in the up-MTA has been manufactured and controlled in accordance with:
o The requirements for authorisation for use/clinical trial/compassionate use,
o Relevant legislation governing the manufacture of medicinal products in the hospital environment (hospital exemption), including the GMP-ATMPs.
o Approved specifications for quality, safety and traceability parameters.

- He/she will perform the tasks of Deputy Technical Manager in the absence of the incumbent whose main function is to verify and certify that each batch produced in the up-MTA has been manufactured and controlled in accordance with:
o The requirements for authorisation for use/clinical trial/compassionate use,
o Relevant legislation governing the manufacture of medicinal products in the hospital environment (hospital exemption), including the GMP-ATMPs.
o Approved specifications for quality, safety and traceability parameters.

He/she is also responsible for monitoring compliance with work standards, supervising and coordinating the activity of all up-MTA departments, reviewing and closing documentation (incidents, change controls, risk assessments, documentation of production batches, etc.).
Communication as interlocutor, with doctors or patients' responsible in the framework of compassionate uses/clinical trials and with the health authority (Spanish Agency of Medicines and Medical Devices, AEMPS).

2.- Requirements to be assessed:

- Accredited knowledge in Good Manufacturing Practice (GMP) and ideally GMP-ATMP.
- Experience in the elaboration of the documentation related to the Quality System of Good Manufacturing Practice (GMP/GMP).
- Proven experience in a manufacturing facility (clean room) in the framework of GMP and/or GMP and/or GMP-ATMPs (ideally in the Quality Assurance Department).
- Regulatory knowledge related to documentation, clinical trial authorisation and authorisations of medicinal products under special conditions (compassionate use).
- Experience in cell culture techniques, handling of viral vectors, tissues and biotechnological techniques.
 

On offer:

-Gross annual salary: 27.052,31 €.

-Working day of 37.50 hours per week.

-Holidays: 22 working days and 6 days for personal matters.

-Incorporation into a multidisciplinary and continuously developing work environment.

In the subject line of the e-mail, please indicate "CANDIDATE FOR QUALITY ASSURANCE MANAGER FOR SALA BLANCA".