Senior Quality Assurance Specialist for CNS Products
hace 1 mes
About Neuraxpharm
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 over 35 years of experience, we have a unique understanding of the CNS market.
We are constantly innovating, with new products and solutions to address unmet patient needs. Our portfolio is expanding through our pipeline, partnerships, and acquisitions. We have a direct presence in more than 20 countries in Europe and globally via partners in over 60 countries.
We are backed by funds advised by Permira and have a team of over 1,000 employees dedicated to developing and commercializing CNS products.
Job Overview
We are seeking a Senior Quality Assurance Specialist for CNS Products based in Sant Joan Despí. This role is responsible for providing confidence that quality requirements are fulfilled. The mission is to provide an effective and efficient quality assurance system that ensures compliance with Good Manufacturing Practice as part of Quality Management.
The successful candidate will be responsible for:
- Writing, reviewing, or approving technical documents: SOPs, master and batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, utilities monitoring, environmental conditions, etc.
- Writing, executing, or reviewing qualifications (equipment, utilities, and facilities) and validations (process, cleaning, IT, and utilities).
- Preparing and executing GMP trainings.
- Ensuring compliance (internal procedures vs. filed documentation).
- Writing and monitoring CAPAs, deviations, and change controls.
- Writing and reviewing Product Quality Review reports.
- Planning, reviewing, and approving calibration activities.
- Executing internal and external audits. Attending audits from Health Authorities and customers.
- Providing support and answering customer queries about assigned products.
- Managing assigned I+D projects.
Requirements
To be successful in this role, you will need:
- 2-5 years of experience in a Quality Assurance Department.
- Bachelor's or Master's degree (ended or in progress) 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.
What We Offer
We offer a competitive salary range of €40,000 - €60,000 per year, depending on experience and skills. You will also receive individual professional development opportunities in a leading European pharmaceutical company with an ambitious international growth strategy. Additionally, you will be part of a motivated and committed environment based on a diverse and inclusive culture.
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