Quality Assurance Specialist
hace 7 días
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 over 20 countries in Europe and globally via partners in over 60 countries.
Our company has more than 1,000 employees and develops and commercializes CNS products. We are backed by funds advised by Permira.
Job Description
As a Quality Assurance Specialist, you will provide confidence that quality requirements are fulfilled. Your mission is to provide an effective and efficient quality assurance system that ensures compliance with Good Manufacturing Practice as part of Quality Management.
Your major accountabilities include:
- 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.
- 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.
- Attending requests related to marketed products regarding quality, administration, and storage.
- Participating in assigned projects.
Requirements
We require:
- 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, and team player mentality, with organizational and prioritization skills.
What We Offer
We offer:
- 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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