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0QA Specialist
16 feb.Neuraxpharm
Sant Joan Despí, ES
QA Specialist
Neuraxpharm · Sant Joan Despí, ES
QA Office
WE ARE HIRING!
Quality Assurance Specialist (Shop Floor)
Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause!
Neuraxpharm is looking for Quality Assurance Specialist (Shop Floor) based in Barcelona
Your Mission
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 Authorization and product specification.
Your Major Accountabilities
- Write, review or approve technical documents: SOP, master and batch manufacturing records, analytical methods, material lists, specifications, OOS, 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, complaints 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.
- Write, execute or review validation activities related to storage and distribution.
- Attend the requests related to marketed products regarding quality, administration and storage.
- Participate on the assigned projects.
- Participate in the approval of suppliers and services.
- Support in the maintenance and monitoring of the quality system.
- Minimum experience of 2 years in a Quality Assurance Department.
- University Degree in Life Sciences or Engineering
- Key Capabilities: Analytical mindset, Communication, Problem Solving and Quality Orientation.
- Expert in GMP and Quality Management System
- Knowledge of: Office, SAP, LIMS, Veeva
- Availability to travel, occasionally to attend courses and conduct audits
- Open mentality to new projects and changes, and commitment with the continuous improvement and promotion of the quality standards stablished in the company
- Language: English is a must
- Interested in afternoon shift (from 14:30 to 22:30)
Neuraxpharm is a 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 and acquisitions.
The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, and globally via partners in more than 40 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
Be part of the team where you can count on us to deliver:
- Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
- Attractive remuneration according to the experience and skills provided.
- An inspiring leadership team that drives performance.
- An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert&excellent team!
- Regular contract
- A QA Shop Floor position in an Afternoon Shift
Have a look at what Neuraxpharm culture represents and what makes us a great place to work: www.neuraxpharm.com
If you want to join us, this is your opportunity!
WE COUNT ON YOU!
At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.
We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.
We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.
