Quality Assurance Technician
We are a Contract Development and Manufacturing Organization (CDMO) with over 20 biotech companies worldwide that have placed their trust in us. We 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.
We are looking for you to be part of our Team!
We are looking for a Quality Assurance Technician to fill this key position reporting directly to the Quality Assurance Manager.
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.
He/she will also provide active support in the continuous improvement of the quality system and more specifically in the implementation of new computer systems and technologies for the overall improvement of the Quality area of the Company.
We value experience in the use of computer systems and in 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 will manage the implementation of the Quality Management system:
- Change Controls.
- Corrective and preventive actions (CAPAs).
- Risk analysis.
- Manage GMP documentation:
- Standard Operating Procedures.
- Standard formulas.
- Analytical methodologies.
- Verify the income of raw materials and GMP materials used in production processes and quality control tests.
- Comply with the supplier qualification plan.
- You will give active support in the implementation of the new computer systems of the Quality area, (ERP, Document Management and management of Change Controls, Deviations and CAPAs).
- You will review and approve the execution of manufacturing guides and analytical techniques.
- You will support the execution of projects: product development, process validations, reporting and preparation of documentation of good practice and GMP behaviour.
- You will support in the execution of audits.
- You will liaise with the Operations and Quality Control department to support them in the management of procedures, change controls and deviations. And you will collaborate to secure the supply of Raw Materials and Materials, through GMP review of all receipts.
- You will have occasional contact with external companies such as quality consultants or suppliers to support the implementation of improvements in the quality system.
- You have university degree studies related to Pharmacy, Biotechnology or related sciences.
- You have knowledge or complementary training in Good Manufacturing Practices: EMA and FDA and training in Biotechnological processes.
- You are fluent in the use of computer systems applicable to Quality Management (ERPs, Documentary Systems, Pharmaceutical Quality Management Systems, etc.).
- We value that you have experience in the Pharmaceutical Industry, in similar functions with GMP Part IV certification (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 possess 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.
We offer you
- You will have continuous career development that will help you develop your talent throughout your entire professional career.
- You will participate in innovative projects in constant technological update.
- You will have a competitive salary according to your profile for this position.
- You will have a flexible timetable, with the support you need to conciliate and balance your personal and professional life.
- You will be part of an expert, young, dynamic, innovative and enthusiastic team united by a common purpose, to accompany our clients to go ahead in the cure of diseases.
- We will support you in your personal change process, if you come from another region and wish to come to live in Donostia-San Sebastián (accommodation, support in the job placement for members of your family unit, schooling,…).
- You will enjoy a professional work environment, which is really distinguished by our humanity and closeness. And where we take care of diversity and inclusion. Diverse viewpoints, your curiosity, bring diverse capabilities that strengthen our focus and fuel our growth.
- We are proud on offering equal opportunities and a close, welcoming environment. All people receive consideration for our vacant positions, without distinction of gender, age, race, religion, identity, sexual orientation, origin, disability or any other characteristic.