Quality Assurance Specialist
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 Specialist to fill a key position reporting directly to the Plant Quality Assurance Director.
Your mission will be to ensure that the necessary activities are carried out in the Company to comply with the applicable “Regulatory Requirements” and the “Quality Management System”.
Likewise, you will be responsible for the continuous improvement of the quality system in its four stages: planning, doing, checking and acting.
You will manage the execution of the Quality Management system: Change Controls, Deviations, Corrective and Preventive Actions and Risk Analysis.
You will manage the GMP documentation: Standard work procedures, Standard Formulas, Analytical Methods.
You will review and approve the execution of manufacturing guides and analytical techniques.
You will give support in the execution of projects: product development, process validations and reporting.
You will give support in the execution of audits.
You are who we are looking for if you have:
- University Degree Studies in Biotechnology, Pharmacy, Biology, etc.
- Training in Correct Manufacturing Standards: EMA and FDA
- Valuable training in biotechnological processes.
- Solid experience of at least 3 years in the pharmaceutical industry in similar functions with certification in Correct Manufacturing Standards Part IV (Guidelines on Proper Manufacturing Standards specific for Advanced Therapy Drugs), with experience in regulated environments under FDA requirements being desirable.
- Demonstrable experience in root cause analysis and risk management.
- High level of English and Spanish
- Solid orientation to high quality, rigor, excellence and self-demand.
- Positive attitude towards change and continuous improvement.
- Good oral and written comunications habilities
- And, above all, a vocation to learn and work because of the team and for the team.
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.