Description of the job:
They are looking for a Quality Assurance – Material Management Technician to fill this key position reporting directly to the Head of Quality Assurance – Material Management. He/she will be responsible for ensuring that the necessary activities are carried out in the Company to comply with the applicable “Regulatory Requirements” and the “Quality Management System” in the Manufacturing and Material Management activities. He/she will also provide active support in the continuous improvement of the quality system and in the implementation of new IT systems and technologies for the overall improvement of the Quality area of the Company. We value experience in the use of computer systems and similar roles within the pharmaceutical industry with certification in GMP Part IV (GMP Guidelines specific to Advanced Therapy Drugs), Annex I Sterile Drug Manufacturing, and experience in regulated environments under FDA requirements, as well as experience in root cause analysis and risk management.
- You have a university degree related to Pharmacy, Biotechnology or related sciences, and a minimum level of English B2.
- You have knowledge or complementary training in Good Manufacturing Practices: EMA and FDA and training in Biotechnological processes.
- You are proficient in the use of computer systems applicable to Quality Management (ERPs, Documentary Systems, Pharmaceutical Quality Management Systems, etc.).
- You have experience in the Pharmaceutical Industry, in similar functions with certification in GMP Part IV (GMP Guidelines specific to Advanced Therapy Drugs), Annex I Sterile Drug Manufacturing, and experience in regulated environments under FDA requirements, as well as experience in root cause analysis and risk management.
- You are a high quality oriented (excellence and self-demanding), organized and orderly person.
- You like to work in a team and be proactive.
- You have good oral and written communication skills.
- You are a responsible and rigorous person in what you do, demonstrating a high capacity for work, when there is a high demand for results and dates.
- You always show a positive attitude towards change.
If you are interested, please send your CV to email@example.com
VIVEbiotech is a Contract Development and Manufacturing Organization (CDMO) with over 20 biotech companies worldwide that have placed their trust in them. They develop and manufacture lentiviral vectors as a European leader working under both EMA and FDA standards. The lentiviral vectors produced by VIVEbiotech are used to treat a range of disorders, including haematological and solid cancers, and rare diseases. They are looking for you to be part of their Team!