![Perrigo](https://media.trabajo.org/img/noimg.jpg)
Associate Computer System Validation
il y a 2 semaines
Description Overview
Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being.
Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage.
You know us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin, Dermalex, Biover, Galenco, Davitamon, Ymea, Lactacyd.
Perrigo is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture.
Location: Ghent, Belgium or Chatillon, France
We offer a Hybrid working schedule, a mix of onsite and remote working each week.
Scope of the Role
Represent QA in computer system validation projects including change controls, deviations and periodic reviews and Data integrity for CSCI Provide support with guidelines and regulations such as GAMP 5, EU GMP Annex 11, and FDA CFR Part 11 Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Perrigo CSCI group Keep going awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD) Support in the maintenance of Quality Systems, including electronical systems (Trackwise, LMS,…) Provide QA training to the entire group (European branch of the Perrigo Company) regarding computer system validation and Data Integrity and evaluate training effectiveness, including the creation of powerpoint presentations, online recorded trainings, etc. Ensure adherence to critical procedures and compliance to requirements for record retention Be part of third-party qualification and regular third-party auditing for all topics related to Computer System Validation and Data integrity Assist in performing internal QA audits Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions. related to Computer Systems and Data Integrity Provide support in establishing and maintaining the ISO 9001 and ISO 13485 Quality Management System related to Computer Systems and Data Integrity Identify gaps and areas for improvement in QA processes related to Computer system and handling and lead remedial actions and initiatives
Experience Required
Bachelor degree in IT, engineering, biochemistry, chemistry or equivalent through experience. You are fluent in spoken and written English, other languages are a benefit. At least 2-5 years relevant experience in Computer system validation in Pharmaceutical and/or Medical Devices industry Deep knowledge of FDA regulations (especially CFR Part 11), EU GMP Annex 11 and GAMP 5. Knowledge of the relevant European regulations for pharmaceutical products (GMP specifically Annex 11, GDP), Medical Devices (MDR, MDD, ISO13485, ISO14971), Food, Food Supplements (HACCP, ISO 22000); Cosmetics (ISO 22716) is an asset
What we can offer you
-
Associate Computer System Validation
il y a 5 jours
Ghent, Belgique Perrigo Temps pleinPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. Description OverviewPerrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being.Originating from the former...
-
QA CSV Systems Associate
il y a 3 semaines
Ghent, Belgique Perrigo Temps pleinDescription Overview Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being. Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage. You know us from brands like Physiomer, NiQuitin, XLS...
-
IT Quality
il y a 2 semaines
Ghent, Belgique Argenx Temps pleinArgenx is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development...
-
QA CSV Manager
il y a 2 semaines
Ghent, Belgique Viroclinics Biosciences Temps pleinCerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to...
-
Product Quality Associate, IMP
Il y a 2 mois
Ghent, Belgique Argenx Temps pleinTo further strengthen our Quality team, we are looking for an experienced and motivated Product Quality Associate, IMP. The Product Quality Associate, IMP will play a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams and will be responsible to ensure the quality oversight of CMO’s involved...
-
Product Quality Associate, IMP
il y a 3 semaines
Ghent, Belgique Argenx Temps pleinTo further strengthen our Quality team, we are looking for an experienced and motivated Product Quality Associate, IMP. The Product Quality Associate, IMP will play a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams and will be responsible to ensure the quality oversight of CMO’s involved...
-
Clinical Study Associate
il y a 3 semaines
Ghent, Belgique Pharmiweb Temps pleinHobson Prior is working closely with a leading pharmaceutical organisation who is seeking a Clinical Study Associate. This role is a permanent position based in Diegem. The successful candidate will be accountable for tracking study documents and ensuring the completeness of the Trial Master File for assigned clinical studies. This role requires proficiency...
-
Associate Professional Services Consultant
il y a 2 semaines
Ghent, Belgique Showpad Temps pleinAssociate Professional Services ConsultantLocationThis role is available for Hybrid working 2 days a week from either Ghent or London Showpad officesAbout ShowpadIn the old days, traveling salespeople hit the road with only a suitcase and a smile. And as times—and technology—have changed, Showpad has emerged as the industry-leading solution for modern...
-
System Engineer
il y a 6 jours
Brussels, Antwerp, Liège, Hasselt, Ghent, Belgique Brainbridge Temps pleinAre you an experienced System Engineer who thrives in the ever-changing world of Information Technology? Then we have exciting opportunities for youWe are looking for multiple Freelance professionals for different projects. Your personal passion, interests and experience will be decisive in setting the right accents and determining your personal journey.Your...
-
Embedded C++ Software developer | Senior
il y a 4 semaines
Ghent, Belgique Dekimo Experts Gent BV Temps pleinTaken en verantwoordelijkhedenDekimo Experts Gent, part of the Dekimo Group, is looking for motivated professionals.Our consultants are involved throughout the whole software & system lifecycle and contribute to the strategy or critical missions for our customers in a wide variety of industry sectors (automotive, medical, aerospace, broadcasting, …).Dekimo...
-
Intune Mobile Device Management Engineer
il y a 19 heures
Ghent, Belgique team.blue Temps pleinOur Business team.blue is an ecosystem of successful brands working together across regions to provide customers with everything they need to succeed online. 40+ successful brands make up the group; within those brands, over 2000 experts serve its 2.5+ million customers across Europe and beyond. team.blue's brands are a mix of traditional hosting...
-
Group Leader Analytical Sciences
il y a 3 semaines
Ghent, Belgique Ardena Temps pleinAbout us Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...
-
Group Leader Analytical Sciences
Il y a 2 mois
Ghent, Belgique Ardena Temps pleinAbout us Ardena is a leading contract development organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integrated portfolio of drug substance and drug product development, manufacturing,...
-
Order management assistant
il y a 4 semaines
Ghent, Belgique ArcelorMittal Temps pleinIntroduction:The Order Management Platform (OMP) is an important link between the customer, the commercial organization and the factory. The OMP books the orders of all European customers in SAP and sends them an order confirmation within 2 to 3 working days. The OMP is responsible for the complete follow-up of the order from receipt to sending out the...
-
Ghent, Belgique KU Leuven Temps pleinYou have a PhD or doctoral degree in Electrical Engineering.You have a strong research track record in the domain, evidenced by publications in good quality/international journals. Industrial experience and international research experience are positive factors. Experience in acquisition of competitive funding is an asset.You have good teaching skills, and...
-
Professor in Applied Power Electronics for Clean Energy Solutions
il y a 3 semaines
Ghent, Belgique KU Leuven Temps pleinYou have a PhD or doctoral degree in Electrical Engineering.You have a strong research track record in the domain, evidenced by publications in good quality/international journals. Industrial experience and international research experience are positive factors. Experience in acquisition of competitive funding is an asset.You have good teaching skills, and...
-
Procesoperator volcontinu
il y a 1 mois
Ghent, Belgique Glowi Jobs Temps pleinTaakbeschrijving Voor een grote chemische speler regio Gent, zijn we op zoek naar een procesoperator die in een volcontinu systeem kan werken.Je staat in voor de productie van folies voor glas.Wat is je takenpakket?- Parameters instellen en controleren - Beschikbaarheid van grondstoffen opvolgen - Proces opstarten - Zaken invoeren in de computer - Bij...
-
Procesoperator volcontinu
il y a 3 semaines
Ghent, Belgique Glowi Jobs Temps pleinTaakbeschrijving Voor een grote chemische speler regio Gent, zijn we op zoek naar een procesoperator die in een volcontinu systeem kan werken.Je staat in voor de productie van folies voor glas.Wat is je takenpakket?- Parameters instellen en controleren - Beschikbaarheid van grondstoffen opvolgen - Proces opstarten - Zaken invoeren in de computer - Bij...
-
Postdoc position in Geomatics
il y a 1 mois
Ghent, Belgique KU Leuven Temps pleinAlthough not restricted to these, you preferably have a background and a Ph.D. in Geomatics, Robotics, Computer Science, Artificial Intelligence, Mathematics.You show particular interest in applied science-technology, and you have an affinity with quantitative approaches towards data science, including relevant developments in the field of geospatial data...
-
Warehouse Associate
Il y a 2 mois
Ghent, Belgique Page Personnel Temps pleinYou process all incoming and outgoing goods in the system.It is your job to store all these goods correctly.Blood samples that arrive must be carefully unpacked and transported to the labs according to our protocols.You make a correct inventory of everything in the warehouse every day.You carry out inspections to ensure that everything is done according to...