Qualified Person
il y a 4 jours
Qualified Person📍Brabant, Walloon Region, BelgiumAbout NalysNalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.Job DescriptionAs a Delegate Qualified Person within the QA team, you will play a key role in ensuring compliance with EU and Belgian regulatory requirements, GMP/GDP standards, and internal quality procedures. You will support both departments QA functions, contributing to the release of clinical trial materials, oversight of quality systems, and regulatory documentation. This role involves collaboration with global quality units, regulatory affairs, and external partners, and may include final release responsibilities for Asian depending on experience.The Role & ResponsibilitiesReporting to the QA leadership team and collaborating with cross-functional stakeholders, your responsibilities will include:Delegate Qualified Person (QP) responsibilitiesPerform QP certification and batch release for Extemporaneous Preparations and FING materialsApprove QP release certificates, retest date extensions, study/country additions, and QP declarationsOversee deviations, change controls, complaints, and redistribution approvalsEnsure clinical trial materials meet regulatory and GMP requirementsParticipate in quality metrics reviews and inform management of critical quality eventsLead and support projects impacting both departments.Interact with internal quality organizations and regulatory bodiesParticipate in regulatory inspections and external auditsManage retention and reference samples at EU packaging partnersCoordinate product retrievals and support Expanded Access ProgramsEnsure timely communication of critical quality issues to management and authoritiesMonitor and ensure effectiveness of CAPAs.Skills & QualificationsYou hold a Master’s degree in Pharmacy or equivalent scientific disciplineYou are recognized as a Qualified Person under EU regulationsYou have minimum 1 year of experience in a pharmaceutical environmentYou are fluently in English, in both spoken and writtenYou work as an expert with GMP/GDP and regulatory complianceYou manage perfectly documentation, communication, and are a problem-solver person.Your TeamYou will be part of the QA Delegate QP team, working closely with different quality units to ensure product safety, regulatory compliance, and continuous quality improvement.The Recruitment ProcessBy applying for the “Delegate Qualified Person” position, you will go through the following steps in our recruitment process:Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screeningYou will have a second interview with one of our technical expertsThe final interview will be with our Business Unit Director, Jimmy Rousseaux.“If you're passionate about pharmaceutical quality and want to contribute to safe and effective products that improve patients’ lives, we’d love to hear from you”
-
Qualified Person
il y a 4 jours
Walloon Brabant, Belgique Nalys Temps pleinQualified Person Brabant, Walloon Region, Belgium About Nalys Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we believe in combining deep...
-
Qualified Person
il y a 4 jours
Walloon Brabant, Belgique Nalys Temps pleinQualified PersonBrabant, Walloon Region, BelgiumAbout NalysNalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we believe in combining deep expertise...
-
Authorised Person
il y a 6 jours
Mons, Walloon Region, WAL, Belgique Mercury Temps pleinAuthorised Person, Mons, Belgium Apply Now Mercury is the European leader in construction solutions. We build and manage complex engineering & construction projects for the world’s leading corporations. Our solutions help deliver technologies and life changing advancements that connect people, communities, and businesses, giving them the...
-
Territory Sales Manager Aftermarket Benelux
il y a 4 jours
Flemish Brabant, Belgique WhatJobs Temps pleinJoin to apply for the Territory Manager After Market Benelux role at Donaldson Donaldson is committed to solving the world’s most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration...
-
Pipeline: Territory Manager
il y a 4 jours
Flemish Brabant, Belgique WhatJobs Temps pleinDonaldson is committed to solving the world’s most complex filtration challenges. Together, we make cool things. As an established technology and innovation leader, we are continuously evolving to meet the filtration needs of our changing world. Join a culture of collaboration and innovation that matters and a chance to learn, effect change, and make...
-
Staff Product Manager, Platform Configuration
il y a 6 jours
Waterloo, Walloon Region, WAL, Belgique Verily Temps plein**Who We Are** Verily is a subsidiary of Alphabet that is using a data-driven approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, our purpose is to bring the promise of precision health to everyone, every day. We are focused on generating and activating data from a variety of sources,...
-
MES and OSIsoft PI Consultant Pharmaceuticals
il y a 6 jours
Braine-l’Alleud, Walloon Region, WAL, Belgique Amaris Consulting Temps plein**Job Description** **Mission** Join the digitalisation program for a leading bio-manufacturing unit, converting paper batch records into electronic workflows via **MES and OSIsoft PI.** You will own specific MES/PI process packages (upstream, downstream, buffer prep) and drive them from user requirements through to qualification. **Key Objectives** -...
-
Storage Pre-sales
il y a 2 jours
Diegem, Flemish Brabant, Belgium Hewlett Packard Enterprise Temps pleinStorage Pre-sales This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office.Who We Are:Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever...
-
Storage Pre-sales
il y a 2 jours
Diegem, Flemish Brabant, Belgium Hewlett Packard Enterprise Temps pleinStorage Pre-sales This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office.Who We Are:Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever...
-
Storage Pre-sales
il y a 2 jours
Diegem, Flemish Brabant, Belgium Hewlett Packard Enterprise Temps pleinStorage Pre-sales This role has been designed as ‘Hybrid’ with an expectation that you will work on average 2 days per week from an HPE office.Who We Are:Hewlett Packard Enterprise is the global edge-to-cloud company advancing the way people live and work. We help companies connect, protect, analyze, and act on their data and applications wherever...
