Quality Assurance y Regulatory Affairs Specialist

Our client, a renowned pharmaceutical company based in Badalona, is seeking a dedicated Quality Assurance and Regulatory Affairs Specialist to join their team. With a focus on quality assurance and regulatory compliance, this role offers a unique opportunity to contribute significantly to the pharmaceutical field while also fostering personal and professional development. The vacancy is 100% office based in Badalona.

Benefits :

– Contribute to maintaining quality standards and ensuring regulatory compliance in the pharmaceutical sector

– Enhance your skills and knowledge in regulatory affairs and quality assurance, paving the way for personal and professional growth

– Engage in a collaborative work environment, working alongside cross-functional teams to achieve organizational goals

Responsibilities :

– Play a vital role in upholding quality standards and ensuring compliance with regulatory guidelines, making a tangible impact in the pharmaceutical field

– Assist in the development and implementation of quality assurance procedures to maintain high standards of product quality and safety

– Collaborate with cross-functional teams to streamline processes and drive continuous improvement initiatives

Requirements : Experience in :

Regulatory Scope :

Creation, management and presentation of documents in NeeS and eCTD format.

Knowledge and use of the Gesfarma tool

Text Review : technical precision, knowledge of regulations.

QA :

Creation of manufacturing specifications for secondary conditioning.

Quality control of packaging materials, guaranteeing their conformity with specifications.

Implementation of quality procedures and maintenance of control records.

Technical direction :

Review of certificates of analysis, batch release and data upload to the EUHub.

Review and writing of SOPs and other quality documentation

Management of quality complaints and non-conformities Knowledge of self-inspections and quality audits

Desirable : Experience in pharmaceutical distribution under BPD regulations

– Possess a Bachelor's Degree in Pharmacy

– Fluent in English and a native Spanish speaker

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About NonStop : We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We're passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting, for more information, to browse all our roles, or to let us know how we can help you.