Quality Assurance Specialist- Qualification
hace 4 meses
bout the Neuraxpharm Group
Neuraxpharm is the leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships and acquisitions.
The company has more than 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, and globally via partners in more than 60 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain.
Neuraxpharm is searching a vacancy based in Sant Joan Despí:
QA Specialist – Qualification and Transport
The External QA Specialist is responsible for maintaining and improving an effective and efficient quality assurance system that ensures the compliance with current regulations (including but not limited to: GMP, GDP and ICH Quality guidelines) to guarantee that medicinal products manufactured by external contract manufacturing organizations (CMOs) are consistently produced, tested and distributed in accordance with the quality standards appropriate to their intended use and as required by the Marketing Authorization, which ensures the quality, efficacy and security of the medicinal products for patients.
Become the expert regarding quality along the distribution of medicinal products worldwide, the assigned markets and their regulations and requirements. Build up and improve a global corporate quality system and raise the quality standard globally.
Being his/her major accountabilities:
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.
WE REQUIRE:
+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, and team player mentality, with organizational and prioritization skills. Availability to travel
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 skillsprovided.
A motivated and committed environment based on a diverse and inclusive culture. Temporary contract of 1 year A specialized team focused on our core activity: Improving our patients’ lives.All interested candidates meeting the above requirements should send their CVs quoting the reference “QA Transport Specialist ” , either by email to: ‘HR email’
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