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 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 Quality Assurance Technician for further development with us. 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 the requirements of the GMP and GDP, regulatory and legal requirements, as well as the development of the necessary actions to maintain a perspective of continuous improvement, taking into account the guidelines and objectives defined by the company.
Main tasks and Responsibilities:
- Collaborate in the development of the Quality Assurance system in accordance with GMP/NCF regulations.
- Develop or supervise QMS procedures or documents.
- Participate in self-inspections or GMP compliance audits.
- Investigation of Deviations, establishment of corrective, preventive and improvement actions, and PQRs.
- Collaborate in the Evaluation and Monitoring of Change Controls.
- Manage and deal with complaints.
- Participate in the GMP qualification of equipment, facilities, analytical methods, processes and/or cleaning procedures: preparation, review and execution 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 dossiers.
- Preparation of product quality PQR reports in accordance with the approved procedure.
- To train company personnel in the area of Quality Management and NCF.
- Collaborate with the head of the QAU to promote compliance with the GMP, proposing modifications and standards in this area.
- Support the different organisational units in the activities of implementation and maintenance of the approved procedures, aiming to increase their degree of participation in continuous improvement actions, risk analysis, and actions for the prevention of contamination and compliance with the applicable legal requirements.
- Management/Maintenance of the company’s electronic ShareMe Document and Quality Management System.
- Collaborate in the supplier qualification process. Processing of the information received and classification of suppliers in levels of approval.
- Annual monitoring of the qualification/validation matrices established in the PMV.
- Monitoring of quality indicators.
- Collaboration in the management of incidents in critical installations or equipment.
- Ensuring the correct maintenance and use of the facilities based on what is described in the GMP.
- Collaboration with the UI department regarding compliance with 21CFR Part 11 and Annex 11 of the GMP (validation of computerised systems, support in the choice of new equipment or systems).
- Ensure the integrity of the data used for correct decision-making in the GxP and business areas.
Requirements:
- Degree in Health Sciences / Pharmacy / Chemistry or similar.
- Specific training in quality.
- Computer skills at user level.
- Fluent English ( spoken and written, minimum B2 or similar ).
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.
