QC Qualification Officer

ph3General information /h3 pQC Qualification Officer /p pThe QC Qualification Officer ensures that QC systems and equipment remain qualified, validated, and compliant, enabling the timely and reliable execution of laboratory testing. The role is responsible for coordinating the full lifecycle of QC equipment and systems, including implementation, maintenance, calibration, qualification, validation, documentation, troubleshooting, user training, and continuous improvement, while ensuring compliance with GMP and regulatory requirements. /p h3Your tasks /h3 ul liCoordinate all work related to QC systems and equipment. /li liMonitor and maintain the qualified/validated status of QC systems and equipment. /li liOrganise and coordinate the maintenance, calibration, and requalification of QC systems and equipment with both internal and external parties. /li liMonitor equipment performance in collaboration with QC groups and propose improvements where appropriate. /li liProvide support in the event of equipment malfunctions. /li liOrganise, execute, and manage the implementation of new QC systems and equipment together with system owners and users. /li liProvide equipment-related documentation, such as operating instructions and logbooks. /li liEnsure that maintenance-, calibration-, qualification-, and validation-related documentation, including procedures, instructions, and equipment files, is kept up to date. /li liCoordinate and ensure that work performed by third parties meets contractual obligations and agreed quality and timelines. /li liWrite, maintain, and follow up on SOPs, Change Controls (CCs), /li liDeviations (Devs), and CAPAs related to the maintenance, calibration, qualification, and validation of QC systems and equipment. /li liPerform troubleshooting for QC systems and equipment. /li liAct as a Subject Matter Expert (SME) in projects and during internal and external audits and inspections. /li liProvide training to equipment users. /li liEducate and engage key users of systems and equipment to enable them to act as backups. /li liIdentify and report opportunities for optimisation and continuous improvement. /li liBe prepared to undertake additional duties as required. /li /ul h3You have /h3 ul liHBO-level laboratory-related or technical education. /li liRelevant work experience with GMP laboratory equipment. /li liExperience with project management is a plus. /li liKnowledge of pharmaceutical QC analytical equipment. /li liKnowledge of computer systems and information technology. /li liKnowledge of GMP guidelines and relevant international regulations related to system management, including validation, change control, and deviation management. /li liGood command of the Dutch and English languages. /li /ul h3Who are we looking for? /h3 pWe are looking for a proactive and results-driven professional who takes ownership of responsibilities and is committed to continuous self-development. You work efficiently, collaborate effectively with colleagues and stakeholders, and have a strong focus on delivering high-quality results. As a tech-savvy professional, you quickly adapt to new technologies and systems and actively contribute to process improvements and operational excellence. /p h3Our offer /h3 ul liYou will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters. /li liA culture that is characterized by entrepreneurial spirit and a friendly and helpful atmosphere. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment. /li liYou will be working in our dynamic headquarters in Leiden, where we work on the full project pipeline from development to commercial production. /li liBeing part of a company that is geared towards helping people live happier and healthier lives. /li liA competitive salary that matches your responsibilities and experience. /li liA 13th month salary /li li30 leave days. /li liCompany contribution to a pension package and health insurance. /li /ul h3Important notice to search firms and recruitment agencies /h3 pHAL Allergy does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HAL Allergy Recruitment via to enquire about a potential recruitment or search agreement with HAL Allergy. /p h3HAL Allergy, for those who seek pharmaceutical innovation /h3 pHAL Allergy is one of the European top players in the development, production and distribution of allergen immunotherapies for the treatment and prevention of allergic diseases. We focus on the development and manufacturing of modified allergen extracts for the therapeutic and diagnostic purposes of respiratory and food allergies. With all our activities the patient's well-being is always top of mind. At Hall Allergy we foster open discussions, an entrepreneurial spirit and close collaborations within the teams and with our international colleagues summing up to more than 300 highly specialized people across various positions. If you too would like to become a part of an innovative and challenging pharmaceutical manufacturer, then this is your perfect opportunity! /p pHAL Allergy is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HAL Allergy is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office. /p /p #J-18808-Ljbffr