12 nov
|
Neuraxpharm
|
Sant Joan Despí
12 nov
Neuraxpharm
Sant Joan Despí
WE ARE HIRING Quality Assurance Systems (QMS) Team Leader/ Deputy Qualified Person 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 a Team Leader Quality Assurance Systems (QMS) based in Spain. Your Mission Lead and continuously improve the site Quality Management System, ensuring that quality processes remain effective, compliant and aligned with Good Manufacturing Practice, the Marketing Authorisation and the registered dossier. The role manages the assigned QA Systems team and provides oversight of documentation, audits, third parties, deviations, change controls and inspection readiness. Your Major Accountabilities
• Lead the QA Systems team, setting priorities, assigning responsibilities and supporting professional development.
• Maintain and improve the site Quality Management System, ensuring compliance with GMP, approved procedures and the filed dossier.
• Own or oversee quality-system processes including document control, deviations, CAPAs, change controls, risk management, validation and training.
• Define, monitor and report quality KPIs and trends, identifying improvement opportunities and ensuring timely corrective action.
• Prepare for and participate in regulatory inspections and internal or external audits, coordinating action plans and tracking closure.
• Manage the local third-party and supplier quality system, including qualification and ongoing performance oversight.
• Prepare and review quality documentation and reports related to complaints, recalls, stability, failed processes, deviations and revalidations.
• Collaborate across functions to embed quality standards,
strengthen compliance and support new projects and organizational changes.
• Where formally appointed as Deputy Qualified Person, perform the applicable batch certification and release responsibilities in accordance with legal and GMP requirements. We would like you to have
• University degree in Life Sciences; Pharmacy, Chemistry or Biology is preferred.
• At least 3 years of experience in a Quality Assurance department within the pharmaceutical industry; 5 years is desirable.
• Strong knowledge of GMP and Quality Management Systems in a pharmaceutical manufacturing environment.
• Hands-on experience with documentation systems, deviations, CAPAs, change controls, audits, supplier quality and inspection readiness.
• Previous experience leading or coordinating a team is highly valued.
• Working knowledge of Office, SAP and LIMS.
• Professional proficiency in English.
• Strong analytical thinking, problem-solving, communication, quality orientation and attention to detail.
• Availability for occasional travel to attend training courses or conduct audits.
About Us
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 40 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 approximately 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, Latin America, the Middle East and Australia, and globally through partners. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals in Spain. What 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 that promotes diversity and enables people to develop their full professional potential. Interested in knowing more? Discover 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, YOU COUNT ON US 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.
📌 Quality Assurance Systems (Sant Joan Despí)
🏢 Neuraxpharm
📍 Sant Joan Despí