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 organization.
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, and regulatory and legal requirements, as well as to develop the necessary actions to maintain a focus on 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 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.
- Collaborate in the evaluation and monitoring of change controls.
- Manage and handle 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.
- Facilitate 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 level of participation 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 electronic ShareMe Document and Quality Management System.
- Collaborate 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 at critical facilities or involving critical equipment.
- Ensuring that the facilities are properly maintained and used in accordance with the guidelines set forth in the GMP.
- Collaboration with the UI department regarding compliance with 21 CFR Part 11 and Annex 11 of the GMP (validation of computerized systems, support 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).
Compensation: as per the Company Agreement (Category 6 of the Chemical Industry 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.
