Quality Assurance Specialist - Medical Devices
hace 26 días
Valencia
In a nutshell ¿Todo listo para enviar su solicitud? Por favor, lea la descripción al menos una vez antes de hacer clic en "Solicitar". Position: Senior QA Specialist Location: Valencia (on-site) Experience: 3-5 years of experience in Quality Assurance within the pharmaceutical industry Want to know more? Are you looking to take the next step in your Quality Assurance career in a demanding, dynamic pharmaceutical environment focused on excellence? At BioNanopharma, we are looking for a Senior QA Specialist to play a key role in quality oversight, regulatory compliance, and continuous improvement across our operations. If you have experience in GMP-regulated environments, enjoy working with technical rigor, and are motivated by collaborating across teams to ensure the highest quality standards, we would love to hear from you. Your mission will be to actively support the effective execution and oversight of Quality Assurance activities, contributing to the maintenance of the Quality Management System, documentation management, deviation handling, CAPA follow-up, audit readiness, and regulatory compliance. In addition, you may support Deputy QP-related activities when required. What are we looking for? We are looking for a professional with solid experience in Quality Assurance, a strong compliance mindset, analytical capabilities, and a continuous improvement approach. We want someone who combines quality vision, attention to detail, cross-functional collaboration, and commitment to both regulatory and business standards. The challenge! Support the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in line with GMP requirements and internal procedures. Manage and maintain QA documentation, including SOPs, work instructions, templates, records, and other controlled documents. Review quality records and provide quality oversight of manufacturing and associated operations. Ensure compliance with approved procedures and applicable regulatory requirements. Participate in the management of deviations, incidents, non-conformities, change controls, and CAPAs. Support investigations, root cause analysis, and follow-up of corrective and preventive actions. Support the preparation, coordination, and follow-up of internal audits, external audits, customer audits, and regulatory inspections. Monitor compliance with applicable pharmaceutical regulations, GMP standards, and internal quality policies. Collaborate cross-functionally to ensure quality requirements are integrated into daily operations and decision-making. Support the design and delivery of training related to GMP, quality procedures, and compliance standards. Contribute to the monitoring of quality KPIs and continuous improvement initiatives within the QA area. Support Deputy QP-related activities when required, according to qualification, business needs, and the applicable regulatory framework. What do you need? ~ University degree in Pharmacy, Chemistry, Biotechnology, Health Sciences, or a related field. ~3-5 years of experience in Quality Assurance within the pharmaceutical industry. ~ Previous experience in GMP-regulated manufacturing environments. ~ Solid knowledge of Quality Management Systems (QMS). ~ Experience in quality documentation management. ~ Knowledge of deviations, CAPAs, change controls, and non-conformities. ~ Experience supporting audits, inspections, and inspection readiness. ~ Knowledge of root cause analysis and pharmaceutical QA operations. ~ Fluent Spanish and English. ~ Knowledge of or exposure to Deputy QP responsibilities will be highly valued. ~ FDA knowledge is a plus. What do we value in you? Customer centricity Speed with quality Adaptability to change and flexibility Innovation Leadership and teamwork Effective communication Growth mindset Business orientation Compliance, integrity, and sustainability We also expect you to: Act with a strong quality and compliance mindset in all activities. Demonstrate rigor, accuracy, and discipline in documentation and QA processes. Collaborate effectively with cross-functional stakeholders. Escalate quality risks and compliance concerns in a timely and constructive manner. Balance operational agility with quality and regulatory requirements. Show accountability, ownership, and reliability in assigned responsibilities. Promote continuous improvement, integrity, and teamwork across the organization. Our benefits! Permanent contract Flexible working hours Free on-site cafeteria On-site parking Professional development and continuous training What’s the selection process like? ~ Initial contact by phone or email. ~1 or 2 interviews (on-site/virtual) with HR and the Technical Management team. ~ Ongoing communication about your application status. Do you think this role is not for you? If this opportunity is not the right fit for you at the moment, we encourage you to stay tuned for future opportunities at BioNanoPharma and share this role with people in your network who may be interested. xcskxlj EQUAL OPPORTUNITIES COMMITMENT At BioNanoPharma, we are committed to fostering an inclusive and diverse workplace and to providing equal opportunities for all candidates. We do not discriminate on the basis of gender, gender identity or expression, ethnicity, nationality, religion, sexual orientation, disability, age, or any other characteristic protected by applicable law.
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