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 Trial headquarters in Zamudio, our only production center 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 Quality Assurance Technician to grow with us in this temporary replacement position, which offers a genuine opportunity for a permanent contract. You will report to the Head of the Quality Assurance Unit in the Technical Directorate.
Mission. To ensure compliance with Roxall’s Quality Management System (QMS) in order to guarantee compliance with GMP, GDP, regulatory, and legal requirements, as well as to implement the necessary measures to foster a culture of continuous improvement, in accordance with the guidelines and objectives established by the company.
Main tasks and Responsibilities:
- Help develop the Quality Assurance system in accordance with GMP/NCF regulations.
- Develop or oversee QMS procedures or documents.
- Participate in self-inspections or GMP compliance audits.
- Investigation of deviations, implementation of corrective, preventive, and improvement actions, and PQRs.
- Help evaluate and monitor change controls.
- Manage and handle complaints.
- Participate in the GMP qualification of equipment, facilities, analytical methods, processes, and/or cleaning procedures: preparation, review, and implementation of plans, validation protocols, and validation reports.
- Promote the approval of the annual plans for calibrations, equipment and facility qualifications and maintenance, cleaning validations, etc., as established in the Validation Master Plan.
- Review of manufacturing and quality control documentation.
- Preparation of product quality PQR reports in accordance with the approved procedure.
- To train company personnel in the areas of Quality Management and NCF.
- Work with the head of the QAU to promote compliance with GMP, proposing changes and standards in this area.
- Support the various organizational units in implementing and maintaining approved procedures, with the aim of increasing their involvement in continuous improvement initiatives, risk analysis, and measures to prevent contamination and ensure compliance with applicable legal requirements.
- Management and maintenance of the company’s ShareMe electronic document and quality management system.
- Participate in the supplier qualification process. Process the information received and classify suppliers into approval levels.
- Annual monitoring of the qualification/validation matrices established in the PMV.
- Monitoring of quality indicators.
- Collaboration in the management of incidents involving critical facilities or equipment.
- Ensuring that the facilities are maintained and used properly in accordance with GMP guidelines.
- Collaboration with the UI department regarding compliance with 21 CFR Part 11 and Annex 11 of the GMP (validation of computerized systems, assistance in selecting new equipment or systems).
- Ensure the integrity of the data used for sound decision-making in the GxP and business areas.
Requirements:
- Degree in Health Sciences, Pharmacy, Chemistry, or a related field.
- Specific training in quality.
- Basic computer skills.
- Fluent English (spoken and written; minimum C1 or equivalent).
Remuneration: according to Company Agreement ( Category 6th Chemical Collective Agreement ).
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.
