Quality Assurance Technician - Spain
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- The successful candidate will join our company as a Technician of the Quality Assurance Department.
- The candidate will be expected to be key member of the Quality Assurance.
- The candidate will be expected to provide quality assurance oversight.
- Proficiency and capability in managing activities in a fast paced environment is expected.
- At least three years’ experience in Quality Assurance from a related industry, with a preference from within the biopharmaceutical industry.
- Draft quality assurance policies and procedures
- Experience training staff in Quality Assurance
- GMP experience
- Audit experience
- CAPA experience
- Ensuring Deviations, CAPA and Change Control are progressed in a compliant and timely manner
- Ensuring complaints and non-conformance issues are investigated in a compliant and timely manner
- Ensuring batches are reviewed and released as required to support business needs
- Participating and supporting internal audits
- Participating and leading risk assessments
- Knowledge of tools, concepts and methodologies of QA
- Capable to identify areas for improvement in the quality system and implement improvement actions
- Knowledge of relevant regulatory requirements
- Proficient verbal and written communicator.
- Proficiency to work within regulatory guidelines.
- Proven initiative and independent thinking to deliver tasks on time, whilst working in a team environment.
- Experience in the preparation and review of documentation (SOPs, Development Reports, Characterization Reports, Qualification reports, Validation Reports) in English to regulatory standards is essential.
- Fluent in English.