Quality Assurance Specialist
hace 2 meses
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 SummaryThe External QA Specialist will be responsible for maintaining and improving an effective and efficient quality assurance system that ensures compliance with current regulations, including GMP, GDP, and ICH Quality guidelines. This role will guarantee that medicinal products manufactured by external contract manufacturing organizations (CMOs) are consistently produced, tested, and distributed in accordance with quality standards.
Key Responsibilities- Write, review, approve, and monitor CAPAs, deviations, OOS, complaints, and change controls.
- Write, execute, or review validation activities related to storage and distribution.
- Write, execute, or review qualifications (equipment, utilities, and facilities) and validations (e.g., process, cleaning).
- Write, review, and approve Product Quality Review reports.
- Perform Compliance checks (internal procedures vs. filed documentation).
- Execute internal and external audits. Attend audits from Health Authorities and customers.
- Prepare and execute GMP trainings.
- Attend requests regarding quality related to marketed products.
- Supervise the quality of the product in the market and drive continuous improvement.
- Support the assigned Product Lifecycle projects.
- Supervise activities of the MAHs and Distributors.
- Supplier qualification management.
- +2 years of experience in a Quality Assurance Department, some knowledge in transport audit. 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.
- Key Capabilities: Analytical thinking, and team player mentality, with organizational and prioritization skills.
- Availability to travel.
- 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.
- Temporary contract of 1 year.
- A specialized team focused on our core activity: Improving our patients' lives.
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