ABOUT US:
We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines (immunotherapy sector).
We have a Technical, R&D and Clinical Trials headquarter in Zamudio, our only production centre for the moment. In this sense, we have a strong growth forecast.
Our value proposition for employees is as follows:
- PEOPLE-CENTRIC: We focus on people.
- SELF-DEMANDING PEOPLE: We promote individual self-demand in pursuit of common achievement.
- CURIOUS PEOPLE: We learn by innovating, valuing the experience that each person can bring to the organisation.
ABOUT THE JOB:
We are looking for a Microbiology Technician for Quality Control ( Zamudio ) to join our team. He/She will report to the Head of Quality Control and will provide support to the group within the Area.
Mission. Ensure the microbiological quality of products and processes through the rigorous execution and documentation of analyses, environmental controls and validations in the area, ensuring compliance with established regulatory and quality standards. Lead the technical and operational organisation of the department, promoting continuous improvement and reliability of results. Contribute to maintaining a safe and controlled production environment that ensures the excellence of the final product.
Main tasks and responsibilities:
- Drafting of all technical documentation related to the department’s tasks: OI, TP, SI, RA and all other technical documentation related to equipment, analytics, sampling, and any other operation related to these tasks.
- Analysis of all samples of production cycle materials that require microbiological control.
- Analysis of all samples requiring endotoxin control.
- Carrying out all environmental controls in the plant.
- Carrying out all analyses related to the API loop.
- Documentation of all analyses performed.
- Validation of microbiological control methods: drafting of protocols and reports and execution of the analytical part.
- Ensuring that all equipment and facilities related to your department are qualified in collaboration with $M.
- Organisation of the work of the department and the staff under your responsibility.
- Drafting of annual reports derived from the control of facilities.
- Management of MDDs and any deviations they may generate.
- Preparation of the relevant part of the PQR reports.
Requirements:
- Degree in biology/chemistry/pharmacy or similar with appropriate training and specific complementary experience in microbiology.
- At least three years’ experience in the pharmaceutical industry, managing the tasks mentioned above.
- Advanced computer skills.
- Fluency in English, minimum C1 (desirable, minimum A1 German)
Salary conditions: According to the candidate’s profile, in line with the sector and functions of the position.
Observations: We are looking for a creative and achievement-oriented technician, with a firm but empathetic leadership style, used to developing relationship models based on trust within his team and to work transversally with the rest of the areas.
