Descripción de la oferta
Quality Specialist - Good Distribution Practice (GDP) Compliance Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Asegúrese de que toda la información de su solicitud está actualizada y en orden antes de inscribirse en esta oportunidad. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. We are looking for a Quality Specialist to join Good Distribution Practice (GDP) Compliance department at Grifols SA. This person will support the team and the Technical Management personnel of the company's commercial subsidiaries and/or internal or external partners in an international environment. What your responsibilities will be Develop procedures, work instructions and manuals of global international scope. Track affiliate quality KPIs and prepare reports, collect, review and compile data in Excel. Coordinate and update contracts, rates and local medicine serialization requirements, ensuring that necessary contracts are signed and reviewed by the relevant department and that fees are paid where appropriate. Request, coordinate, review and compile global information that Headquarters requests from subsidiaries (corporate responsibility report, Retention Polices, etc.). Preparation of technical presentations (PowerPoint, etc.). Provide technical support to subsidiaries in documentation systems and use of Quality System computer tools. Provide support in the process of training in SOPs. Who you are Bachelor's Degree in Life Sciences field (Pharmacy, Chemistry or similar). Master's degree in Pharmaceutical Industry or a related area is a plus. Valuable experience in a similar role within pharma industry and/or medical devices. Valuable to have knowledge of regulations in the Quality field, such as GxP. Advanced level of English. Proficient user of Microsoft Office. Knowledge of SAP is a valuable. You are meticulous and detail oriented. You have excellent communication and teamwork skills, as well as initiative and results orientation. What we offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. Grifols is an equal opportunity employer. Schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time). Benefits package Contract of Employment: Temporary position Flexibility for U Program: Hybrid Location: Sant Cugat del Vallès Contract Logistics Quality Specialist Healthcare Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. Mission From Quality Assurance we are looking for a Corporate Quality Auditor who will be the responsible to perform the Corporate Quality audits to the companies of Grifols Industrial group and affiliates, in order to evaluate and ensure the compliance of Good Distribution Practices, internal procedures and internal policies as well as to detect opportunities for improvement and best practices. Audits will be performed to Biopharma, Diagnostic and Healthcare busines units manufacturing sites (Pharmaceutical products and Medical Devices) and Grifols Affiliates. What your responsibilities will be Collect and review all documentation required to prepare and execute audit activities. Define and coordinate the audit agenda, ensuring alignment with audit objectives and stakeholders. Prepare all audit-related documentation prior to audit execution, including checklists, working papers, and supporting materials. Conduct Corporate Quality Audits, ensuring compliance with the approved audit plan, scope, and timelines. Prepare comprehensive audit reports, clearly documenting activities performed, identified risks, findings, and opportunities for improvement in a timely manner. Evaluate, classify, and document audit findings according to established quality standards, providing practical recommendations for improvement. Follow up on corrective and preventive actions (CAPAs) derived from audits, monitoring implementation and effectiveness. Support the management, monitoring, and reporting of quality indicators and key performance metrics within the area. Collaborate with internal stakeholders to promote continuous improvement and compliance across the organization. Ensure adherence to corporate quality standards, regulatory requirements, and internal procedures throughout the audit process. Who you are You have a Life Sciences Degree (Pharmacy, Biology, Chemistry, Biotechnology) or Engineering Degree (Chemical or Industrial) or 10 years experience. You have 3-5 years of experience in GDP within pharmaceutical industry. High valuable to have experience in Auditing GxP. Strong analytical and communication skills. Availability to travel approximately 30%. Advanced English level, both written and spoken. What we offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. Grifols is an equal opportunity employer. Flexibility for U Program: Hybrid Model Flexible schedule: Monday-Thursday 7-10 to 16-19h and Friday 8-15h. (with the same flexible start time). Benefits package Contract of Employment: Permanent position Location: Sant Cugat del Vallès. Quality Specialist - Good Distribution Practice (GDP) Compliance (Spanish)¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y medicina transfusional y desarrollamos, producimos y comercializamos medicamentos, soluciones y servicios innovadores en más de 110 países y regiones. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities, fostering an inclusive environment where diversity makes us outstanding. Mission To review and ensure that all procedures, testing methods and reports established in GEPD Plasma Testing Laboratories are in compliance to Egyptian regulations, and in accordance to cGMP, following Plasma Testing Specifications established and European Regulation. To manage and supervise Plasma Testing Laboratories Quality projects. To propose continuous improvement measures related to the quality systems of the Laboratories. To supervise the Quality Risk Management (QRM) process for the Laboratories. What your responsibilities will be To review and ensure that all procedures established are in accordance to cGMP. To supervise GEPD Plasma Testing Laboratories quality system and quality culture. To ensure investigation for incidents are initiated, as well as root cause analysis are properly in place. To participate and support internal and external regulatory inspections and audits performed in the Laboratories. To manage and supervise Plasma Testing Laboratories Quality projects. Actively participate in Laboratory meetings for the follow-up of activities related to open Change Controls. Coordinate the tasks required to be developed within the different areas of the company. Review new procedures and processes to be implemented in the Laboratory under the scope of the Change Controls open. To ensure continuous improvement measures related to the quality systems of the Laboratories. To supervise the monitoring of corrective and/or preventive actions implemented within the Laboratories. Ensure their proper implementation and effectiveness. To monitor quality system indicators. To propose improvements in the Laboratory's processes to enhance the quality system. To supervise the Quality Risk Management (QRM) process for the Laboratories. To supervise Quality Risk assessment studies and reports, as well as coordinate mitigation tasks. Who you are Bachelor's Degree in Life Sciences (Biology, Pharmacy, Biotechnology or related fields) Minimum 3-5 years of experience in a related field. Organized and able to manage time effectively. Ability to work within a highly regulated, labor intensive environment. Ability to understand, explain, follow, and enforce SOPs. Ability to plan, communicate and execute activities for the improvement of overall operations. Strong integrity and commitment to Quality and Compliance. Excellent oral and written communication skills to produce clear and concise factual findings. Advanced level of Spanish and English. This position requires significant travel and on-site presence in Egypt, with approximately 50% of the role based in Egypt. What we offer It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help. Grifols is an equal opportunity employer. Flexibility for U Program: Occasionally Remote. Benefits package Contract of Employment: Permanent position. xkdbapo Location: Sant Cugat del Vallès. #J-18808-Ljbffr
