QA Specialist
hace 5 meses
About 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
Quality assurance Specialist is focused on providing confidence that quality requirements are fulfilled. The mission is to provide an effective and efficient quality assurance system that ensures the compliance with Good Manufacturing Practice as a part of Quality Management which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the Marketing Authorisation and product specification.
Being his/her major accountabilities:
As Quality Assurance Specialist: Write, review or approve technical documents: SOP, master and batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, utilities monitoring, environmental conditions, etc. Write, execute or review qualifications (equipment, utilities and facilities) and validations (process, cleaning, IT and utilities). Prepare and execute GMP trainings. Compliance (internal procedures vs filed documentation). Write and monitor CAPAs, deviations and change controls. Write and review Product Quality Review reports. Plan, review and approve calibration activities. Execute internal and external audits. Attend audits from Health Authorities and customers. Attend the requests related to marketed products regarding quality, administration and storage. Participate on the assigned projects. As Quality Shopfloor specialist. CAPA, deviation and change control management. Management of plant and laboratory calibration plan Production shopfloor QA area Write and review Product Quality Review reports for assigned products. Review packaging effervescent area qualifications.o To give support and answer of customer’s queries about the assigned products.
o To manage the assigned I+D projects.
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.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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