Quality Assurance Expert
hace 1 mes
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, including psychiatric and neurological conditions. With over 35 years of experience, the company has developed a unique understanding of the CNS market.
The company is committed to innovation, with a diverse portfolio of products and solutions that address unmet patient needs. Neuraxpharm is expanding its presence globally through partnerships and acquisitions, with a strong direct presence in Europe and beyond.
Job DescriptionWe are seeking a Quality Assurance Specialist to join our team based in Sant Joan Despí. As a Quality Assurance Specialist, you will play a key role in ensuring the compliance of our products with Good Manufacturing Practice (GMP) regulations.
Your primary responsibilities will include:
- Developing, reviewing, and approving technical documents such as SOPs, master and batch manufacturing records, analytical methods, and material lists.
- Conducting equipment, utilities, and facilities qualifications, as well as process, cleaning, IT, and utilities validations.
- Preparing and executing GMP trainings for personnel.
- Ensuring compliance with internal procedures and filed documentation.
- Managing CAPAs, deviations, and change controls.
- Writing and reviewing Product Quality Review reports.
- Planning, reviewing, and approving calibration activities.
- Executing internal and external audits, including those from Health Authorities and customers.
To be successful in this role, you will need:
- A Bachelor's or Master's degree in Pharmacy, Life Sciences, Engineering, or Chemistry studies.
- A minimum of 2-5 years of experience in a Quality Assurance Department.
- Proficient English and Spanish language skills.
- Specific knowledge of GMP, Quality Management System, and IT systems such as Office, SAP, and LIMS.
We offer a competitive salary range of €45,000 - €65,000 per year, depending on your experience and skills. Additionally, you will enjoy individual professional development opportunities in a dynamic and innovative environment. Our company values diversity and inclusivity, and we strive to create a motivated and committed team focused on improving patients' lives.
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