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About Neuraxpharm Group
Neuraxpharm stands as a premier European specialty pharmaceutical organization dedicated to addressing central nervous system (CNS) disorders, encompassing both psychiatric and neurological conditions. With over 35 years of expertise, the company possesses a profound understanding of the CNS market.
Constantly pushing the boundaries of innovation, Neuraxpharm develops new products and solutions to meet unfulfilled patient needs while expanding its portfolio through strategic pipelines, partnerships, and acquisitions.
Employing over 1,000 professionals, Neuraxpharm develops and markets CNS products through direct operations in more than 20 European countries and collaborates with partners in over 60 countries worldwide. The company is supported by funds advised by Permira.
Many of Neuraxpharm's pharmaceutical products are manufactured at Neuraxpharm Pharmaceuticals in Spain.
Neuraxpharm is currently seeking a qualified individual for a position based in Sant Joan Despí:
QA Specialist – Qualification and Transport
The External QA Specialist plays a crucial role in upholding and enhancing a robust quality assurance framework that ensures adherence to current regulations, including but not limited to GMP, GDP, and ICH Quality guidelines. This is essential for guaranteeing that medicinal products produced by external contract manufacturing organizations (CMOs) are consistently manufactured, tested, and distributed in compliance with the quality standards required for their intended use, as mandated by the Marketing Authorization, ensuring the quality, efficacy, and safety of medicinal products for patients.
Responsibilities include:
- Drafting, reviewing, approving, and monitoring CAPAs, deviations, OOS, complaints, and change controls.
- Conducting validation activities related to storage and distribution.
- Performing qualifications (equipment, utilities, and facilities) and validations (e.g., process, cleaning).
- Compiling and approving Product Quality Review reports.
- Executing compliance checks (internal procedures vs filed documentation).
- Conducting internal and external audits, including attendance at audits from Health Authorities and customers.
- Preparing and delivering GMP training sessions.
- Addressing quality-related inquiries concerning marketed products.
- Overseeing product quality in the market and driving continuous improvement initiatives.
- Supporting assigned Product Lifecycle projects.
- Supervising activities of the Marketing Authorization Holders (MAHs) and Distributors.
- Managing supplier qualification processes.
Requirements:
- A minimum of 2 years of experience in a Quality Assurance Department, with some knowledge of transport audits. A Bachelor's or Master's degree (completed or in progress) in Pharmacy, Life Sciences, Engineering, or Chemistry is required. Proficiency in English and Spanish is essential. Specific knowledge in GMP and Quality Management Systems is expected, along with IT skills in Office, SAP, and LIMS. Experience as a Qualified Person (QP) is advantageous. Key competencies include analytical thinking, teamwork, organizational skills, and prioritization abilities.
- Willingness to travel.
We Offer:
- Opportunities for individual professional development within a leading European pharmaceutical company that has an ambitious international growth strategy.
- Competitive compensation based on experience and skills.
- A supportive and committed work environment that values diversity and inclusivity.
- A temporary contract for a duration of 1 year.
- A specialized team focused on enhancing the lives of our patients.
Interested candidates who meet the specified requirements are encouraged to submit their CVs, referencing the position.
