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Analytical technical expert (external CLO /CMO)
Ghent
The Company Our Client is a multinational and innovative global healthcare company. Their teams across the world strive to transform the practice of medicine, turning the impossible into the possible for patients. In Belgium they have 4 sites and 1500 employees. The team Specialty Care External Supply Quality (SCES Q) is the quality unit responsible for GxP oversight of Contract Manufacturing Organizations (CMOs), Contract Laboratory Operations (CLOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. SCES Q has responsibility for CMO and CLO activities related to products treating Rare Diseases and Blood Disorders, Multiple Sclerosis (MS), cancer, and diabetes. In order to reinforce their team, they are looking for an Analytical technical expert (external CMO/CLO) Responsibilities You are responsible for supporting the management of Contract Laboratory Organizations (CLOs) for release and stability of drug substance, drug products and diluent testing. You will coordinate sample shipment, deviations, change controls, CAPAs, method improvements and gap assessments. You will coordinate and manage qualified materials program. You will coordinate/Lead multiple site/global projects and represent QC across organizations. You will contribute to the operation of Stability and Quality release testing programs across a multiproduct portfolio, managing timelines to meet corporate goals. You will execute reagent requests from testing labs (including in-country testing, method transfers) and arrange internally shipment (many countries require special documents) You ‘ll generate release Certificate of analysis from external testing results, assuring compliance to internal specifications. You will originate of ICH compliant stability protocols and reports, coordinate, review, trend, and report stability test data for commercial and clinical drug product You will contribute to the preparation and review of CMC stability sections for clinical regulatory filings, MAA, and BLA; You will contribute to stability and quality sections of Annual Product Review Collaborate with Quality, internal functional areas, and CLOs to generate, review and approve documentation, including: SOPs, analytical test methods, change controls, deviations, CAPAs and OOS/OOT investigation reports You will track sample testing status; enter results into LIMS as needed; and Compile and generate stability data tables and reports for commercial and clinical products for annual product reviews Qualification, Education & Work Experience You hold a BS/MS in a scientific discipline with a minimum of 8 years of experience in the pharmaceutical /biotechnology industry. An advanced degree is preferred, along with experience ideally working with external partners (e.g. contract laboratories and suppliers); A quality Control (QC) experience is necessary, ideally working with external partners (e.g. contract laboratories and suppliers); A LIMS experience preferred but not mandatory; You have an In-depth knowledge of FDA/EMA regulations and compliance and can apply that knowledge effectively within a team/project environment Our client offers Variety in your work assignments Good salary package and additional conditions An international, dynamic and challenging workplace. Extensive trainings and an attractive career path Dynamic colleagues who like good teamwork and lots of employee activities Our client Core Values Teamwork Courage Integrity Respect
Assets Safety Officer
Brussels
Together with others colleagues, activities that fall into the responsibilities of the SAFETY OFFICER in support to the Safety, Quality & Competence Manager: Proactively ensure and facilitate a sustainable implementation of the mainly identified pillars namely operational documentation management, staff training and certification process, reporting of unwanted events, realization of Field Visits and bi-directional dialogue between technical operational teams, OCE team and the Internal Prevention Service: Ensure the ownership of the whole process for the different pillars (process, documentation, reviews, updates management,...) Operational Safety Documentation Manage existing and new documentation (safety instruction in relation to Operational work methods). Identify the need for new / adapted documents Initiate, scoop, arbitrate and lead as a leader a specific Working Group, involving the concerned experts in order to write /update instructions. For summary instruction updates or those with a lower level of operational expertise, ensure the updating of the document (under the supervision of an expert). Identify and plan the rollout of the action plan, with the concerned line managers, in terms of training, communication and implementation following a instruction. Follow up on the complete rollout in the field. Organize/perform reviews of the correct application of the work methods. Develop and monitor improvement action plans. Training & Certification Manage and optimize existing and new training. Identify the needs of new / adapted training. Ensure the development and implementation of the training. Organize within the business the holding of trainings. Field Visits (combined with Quality) Carry out field visits (observation, review) on a recurring basis. Analyze and consolidate the observations made. Ensure the quality and impact (feedback, questioning, rout causes) of these. Ensure coaching / debriefing of the observatory. Take part in the quarterly / annual consolidation meeting in order to identify trends and necessary improvements and take part in the elaboration of the N+1 action plan Analyze transversally the findings of the Audits carried out by the business. Deduce actions and improvements. Ensure the implementation of these in the organization. Identify the needs of new audits, develop and implement them in the business. Prepare and participate in blank or certification audits (ISO, SCL), their debriefings and elaboration of corrective action plans (non-conformities). Ensure, as SPOC (or Project Leader, Expert), for Assets the follow-up of specific projects related to Safety.
8 days to apply
Technisch Project Manager
Antwerpen
Voor een klant van ons, gelegen in het Antwerpse, zoeken we een multidisciplinair project manager met een ingenieur-achtergrond. Als project manager is dit een greep uit jouw takenpakket:  Aansturing van de externe engineering bedrijven om zo succesvolle projecten te realiseren en dit in een veilig, milieuvriendelijk, functioneel/ergonomisch en kwalitatief ontwerp Opvolging en controle van de prioriteiten en de projectmijlpalen van de projecten zodat de planning kan gerespecteerd worden Kostenopvolging van de projecten en correctie van de kostenraming Evaluatie van de projectsituatie en melding van over- en underruns aan het hoofd van de afdeling Engineering  Controle of alle technische documenten die van buiten de klant komen, overeenstemmen met de laatste procedures, specificaties en de praktijk  Bestelling van alle materiaal waarvoor technische specificaties nodig zijn, samen met de afdeling aankoop  Overleg met alle betrokken afdelingen zodat een vlotte integratie van het project kan verzekerd worden Ontwikkeling van technische concepten en oplossingen voor problemen bij projecten om de objectieven van het project te kunnen realiseren Ontwikkeling van technische en projectkennis door training over nieuwe technologieën en verbetering van de know-how van het projectmanagement Opstelling van ramingen en projectschema´s Nazicht van gebruikelijke specificaties en eventueel deelname aan netwerking van de groep om advies te geven
56 days to apply
Test Specialist
Amsterdam
Jouw passie is onze passie Als wij ergens een passie voor hebben is het tech. Wij werken graag samen met mensen die hier hetzelfde instaan. Zo kunnen wij betrokkenheid creëren en vrijheid garanderen. Ons team gaat vanuit hun passie continu de uitdaging aan om grensverleggend te zijn. Dit doen wij bij de opdrachtgever door mee te denken en vooruitstrevend te zijn. Klinkt dit voor jou als muziek in de oren? Dan maken wij graag kennis met jou!  Waar staan wij voor Wanneer jij onderdeel van Open Web bent, moet jij kunnen doen wat jij het liefste wil en waar jouw kracht ligt. Het is voor ons belangrijk dat iedereen met veel plezier aan een opdracht werkt en het interessant vindt. Wij bieden jou daarnaast graag de mogelijkheid om jezelf continu te blijven ontwikkelen, dit kan door onze maandelijkse kennissessies of door een persoonlijk opleidingstraject. Daarnaast kan jij jouw passie en kennis delen met de kinderen van de toekomst tijdens ons evenement Devoxx4Kids. Haal bij ons het beste uit jezelf (en anderen), want jij bent degene die centraal staat.  · Opstellen testgevallen; (in Xray) · Testgevallen overleggen met het team voor eventuele aanpassingen; · Requirements verzamelen en beoordelen, waar nodig duidelijkheid creëren; · De juiste testdata vinden en eventueel creëren in de acceptatie omgeving; · Uitvoeren van de (integratie/systeem) testgevallen en documenteren; (in Confluence en Xray) · Het interpreteren van logs als een test gefaald is, en deze bespreken met de ontwikkelaar; · Resultaten bespreken met de business; · Deelnemen aan de daily stand-ups en meedenken over de ontwikkeling van de applicatie; · Inwerken nieuwe testers en business analisten; · Het helpen transformeren naar SCRUM van verschillend teams;
€3500 - €4500
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