11 ago
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Roxall Medicina España
|
Zamudio
11 ago
Roxall Medicina España
Zamudio
ABOUT US We are dedicated to the research, design, validation, manufacture and distribution of anti-allergic vaccines, within the allergen immunotherapy sector. Our Technical, R&D; and Clinical Trials headquarters are located in Zamudio, which is also currently home to our only manufacturing site. In this context, we have a strong growth outlook for the coming years.
Our value proposition for our people is based on: PEOPLE-CENTRIC: We put people and their professional development at the centre of what we do.
SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in pursuit of shared goals.
CURIOUS PEOPLE: We learn through innovation and value the experience and knowledge that each person brings to the organisation.
ABOUT THE JOB We are looking for a Quality Control Technician to join our team in Zamudio. The position will report to the Head of Quality Control and will be part of the Quality Control area within our Technical Directorate.
Mission To perform the activities assigned by the Head of Quality Control in accordance with the objectives established for the area, ensuring the proper execution, review and documentation of laboratory and analytical activities in compliance with applicable procedures, specifications, GMP requirements and quality standards. Main Tasks and Responsibilities Perform, review and document Quality Control testing of raw materials, materials, intermediate products and finished products, using established analytical techniques and in accordance with approved procedures and specifications.
Perform and review physicochemical, biochemical and/or instrumental analytical testing within the Quality Control laboratory, ensuring the reliability, accuracy and traceability of the results obtained.
Organise and manage assigned analytical activities, ensuring compliance with deadlines, approved procedures, specifications and applicable GMP requirements.
Evaluate analytical results, identify potential atypical or out-of-specification results, and participate in the documentation,
investigation and follow-up of OOS, OOT and deviations related to laboratory activities.
Participate in the transfer, implementation, verification and/or validation of analytical methods, as well as in the activities required to ensure their appropriate performance during routine use.
Participate in the qualification, calibration, verification and monitoring of laboratory equipment and instruments, including the performance and documentation of applicable internal calibrations.
Prepare, review and maintain GMP documentation related to Quality Control activities, including Standard Operating Procedures (SOPs), instructions, protocols, reports, specifications, analytical methods and records.
Record and review data generated during analytical activities, ensuring compliance with data integrity, traceability and Good Documentation Practices (GDP).
Collaborate in investigations, risk assessments, Corrective and Preventive Actions (CAPAs) and Change Controls related to Quality Control activities.
Participate in continuous improvement initiatives within the laboratory, identifying and proposing improvements to analytical methods, procedures, equipment, organisation and working practices.
Work cross-functionally with other departments, particularly Quality Assurance, Manufacturing and R&D;, on activities requiring Quality Control support or analytical expertise.
Comply with applicable requirements and internal procedures regarding GMP, occupational health and safety, hygiene and environmental protection.
Perform any other activities related to the position that may reasonably be assigned by the direct and/or functional manager in accordance with the applicable professional group.
Requirements University Degree in Biotechnology.
Specific training and/or professional experience in Quality Control and Pharmaceutical Quality Systems, with knowledge of GMP requirements.
At least 3 years of professional experience in a Quality Control laboratory, preferably within the pharmaceutical or biotechnology industry or another comparable regulated environment.
Hands-on experience in performing and reviewing physicochemical, biochemical and/or instrumental analytical techniques.
Experience in the investigation and management of OOS, OOT and deviations, as well as in the preparation and review of GMP documentation.
Experience in analytical method transfer, verification and/or validation, as well as laboratory equipment qualification or calibration, will be considered an advantage.
Ability to interpret analytical results, identify trends or deviations and participate in the resolution of technical and analytical issues.
Knowledge of Data Integrity principles and Good Documentation Practices (GDP).
Fluent English, both written and spoken, with the ability to understand and work with technical documentation (C1).
Good command of standard IT tools and experience working with laboratory and/or electronic documentation management systems. REMUNERATION According to the Company Agreement and the applicable professional classification under the General Collective Agreement for the Chemical Industry. THE PROFILE WE ARE LOOKING FOR We are looking for a rigorous, organised and results-oriented professional, capable of working autonomously within a Quality Control laboratory and comfortable working in a highly regulated environment.
We particularly value strong analytical and problem-solving skills, attention to detail, a quality-driven mindset, the ability to manage priorities effectively, and a collaborative approach based on trust and effective cross-functional relationships.
📌 Quality Control Technician (Zamudio)
🏢 Roxall Medicina España
📍 Zamudio