Quality Assurance Specialist- Qualification
hace 2 semanas
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.
The company has a unique understanding of the CNS market built over 35 years and is constantly innovating with new products and solutions to address unmet patient needs.
As a Quality Assurance Specialist, you 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.
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.
Requirements:
- 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.
- QP experience is valuable.
Key Capabilities:
- Analytical thinking, team player mentality, with organizational and prioritization skills.
We offer individual professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
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