Quality Assurance Specialist
hace 4 semanas
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. With a unique understanding of the CNS market built over 35 years, the company is constantly innovating, with new products and solutions to address unmet patient needs.
Job DescriptionAs a Quality Assurance Specialist, you will be responsible for providing confidence that quality requirements are fulfilled. Your mission will be to provide an effective and efficient quality assurance system that ensures compliance with Good Manufacturing Practice as part of Quality Management.
Key Responsibilities:- Write, review, or approve technical documents, including SOPs, master and batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, utilities monitoring, and environmental conditions.
- Write, execute, or review qualifications (equipment, utilities, and facilities) and validations (process, cleaning, IT, and utilities).
- Prepare and execute GMP trainings.
- Ensure compliance with internal procedures versus filed documentation.
- Write and monitor CAPAs, deviations, and change controls.
- Write and review Product Quality Review reports.
- Plan, review, and approve calibration activities.
- Execute internal and external audits, attending audits from Health Authorities and customers.
- Support customer queries about assigned products.
- Manage assigned I+D projects.
- 2-5 years of experience in a Quality Assurance Department.
- Bachelor's or Master's degree (ended or in process of) in Pharmacy, Life Sciences, Engineering, or Chemistry studies.
- Proficient level of English and Spanish.
- Specific Knowledge: GMP, Quality Management System, IT: Office, SAP, LIMS.
- QP experience is valuable.
- Key Capabilities: Analytical thinking, team player mentality, organizational, and prioritization skills.
- Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
- Economic conditions will be according to the experience and skills provided.
- A motivated and committed environment based on a diverse and inclusive culture.
- A specialized team focused on our core activity: Improving our patients' lives.
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