Quality Assurance Technician – Qc & Analytical Validation - Roxall Medicina España

Roxall Medicina España; País Vasco; Presencial; EUR 32.000 - 42.000; Jornada completa

Descripción de la vacante

Roxall Medicina España is seeking a Quality Assurance Technician with strong QA/QC expertise to ensure compliance with the company’s QMS and GMP, GDP, regulatory and legal requirements. You will focus on quality control activities, analytical results, and method validation.

The role reports to the Head of the Quality Assurance Unit within the Technical Directorate, contributing to continuous improvement and collaboration across QA, QC, R&D and other technical areas.

Formación

• University degree in Biochemistry, Biotechnology, Pharmacy, Chemistry or related discipline.
• Minimum 2 years’ experience in a GMP-regulated pharmaceutical laboratory.
• Experience with review of analytical results and OOS investigations.
• Experience with analytical method validation and GMP documentation.
• Knowledge of EU GMP requirements and ICH Guidelines.
• Fluent English (written and spoken, C1 level).

Responsabilidades

• Prepare, review or supervise QMS procedures and documentation for Quality Control.
• Review analytical results and participate in investigations of deviations and CAPAs.
• Contribute to Product Quality Reviews (PQRs) and Change Controls.
• Provide QA oversight of analytical method validation activities and reports.
• Collaborate on validation activities for manufacturing processes and cleaning procedures.
• Train personnel on Quality Management and GMP requirements.

Conocimientos

GMP experience

Analytical method validation

OOS investigations

CAPA & Change Controls

Data Integrity

English proficiency (C1)

Educación

Biochemistry/Biotechnology/Pharmacy/Chemistry degree

Descripción del empleo

We are dedicated to the research, development, manufacture and distribution of allergen immunotherapy products, contributing to improving the quality of life of patients worldwide through innovative healthcare solutions.

Our Technical, R&D and Clinical Trials headquarters are located in Zamudio, where our manufacturing site is also based. As part of our growth and expansion plans, we are looking for talented professionals committed to quality, innovation and continuous improvement.

Our values:

• PEOPLE-CENTRIC: We put people at the centre of everything we do.
• SELF-DEMANDING PEOPLE: We encourage individual accountability and high standards in pursuit of shared success.
• CURIOUS PEOPLE: We continuously learn and innovate, valuing the unique experience and perspectives that each person brings to the organisation.

ABOUT THE JOB

We are looking for a Quality Assurance Technician with a strong specialisation in Quality Control to join our team and continue developing professionally with us.

The successful candidate will report to the Head of the Quality Assurance Unit, within the Technical Directorate.

Mission

To ensure compliance with Roxall’s Quality Management System (QMS) and with applicable GMP, GDP, regulatory and legal requirements, with a particular focus on Quality Control activities, analytical results and analytical method validation.

The position will also contribute to the implementation of the actions required to maintain a continuous improvement approach in accordance with the company’s guidelines and objectives.

Main Tasks and Responsibilities

• Prepare, review or supervise Quality Management System (QMS) procedures and documentation, particularly documentation related to Quality Control activities.
• Review analytical results and participate in the investigation of Out-of-Specification (OOS) results, deviations and other quality events, as well as in the definition and follow-up of Corrective and Preventive Actions (CAPAs).
• Participate in the preparation and review of Product Quality Reviews (PQRs).
• Collaborate in the evaluation and follow-up of Change Controls.
• Participate in the GMP qualification of equipment and facilities.
• Provide Quality Assurance oversight of analytical method validation activities, including the review of validation plans, protocols and reports.
• Collaborate in the review of validation activities related to manufacturing processes and cleaning procedures, where applicable.
• Review manufacturing batch records and Quality Control documentation.
• Train company personnel in Quality Management and GMP requirements.
• Collaborate with the Head of the Quality Assurance Unit to promote GMP compliance and propose improvements to the Quality Management System.
• Support different organisational units in the implementation and maintenance of approved procedures, promoting continuous improvement, quality risk management, contamination prevention and compliance with applicable regulatory requirements.
• Collaborate in the supplier qualification process, managing the information received and supporting supplier classification according to established approval levels.
• Collaborate with the IT/UI department to ensure compliance with 21 CFR Part 11 and EU GMP Annex 11, including computerised system validation and support in the selection of new equipment or systems.
• Ensure Data Integrity principles are applied to data used for decision-making in GxP and business environments.

REQUIREMENTS

• University degree in Biochemistry, Biotechnology, Pharmacy, Chemistry or a related scientific discipline.
• At least 2 years of professional experience in a GMP-regulated pharmaceutical laboratory, preferably in Quality Assurance/Quality Control or Analytical Development.
• Practical experience in the review of analytical results and investigation of OOS and/or deviations.
• Experience in analytical method validation.
• Experience working under EU GMP requirements.
• Knowledge of Quality Systems and applicable ICH Guidelines.
• Fluent English, both written and spoken, minimum C1 level or equivalent.
• Additional training in Pharmaceutical Quality Control, Analytical Validation and/or Quality Assurance.
• Experience with biological products, allergen immunotherapy products and/or sterile products.
• Experience with CAPAs, Change Controls, PQRs and GMP documentation.
• Knowledge of 21 CFR Part 11, EU GMP Annex 11 and Data Integrity principles.

REMUNERATION

According to the Company Agreement (Category 6 of the Chemical Industry Collective Agreement).

PROFILE

We are looking for an analytical, rigorous and results-oriented professional who is comfortable working cross-functionally with Quality Assurance, Quality Control, R&D and other technical areas.

The ideal candidate will combine a strong scientific and analytical background with a clear commitment to GMP compliance, analytical quality, robust documentation, investigation of quality events and continuous improvement.