On that role, you will ensure compliance with electronic data integrity (e-DI) processes in QC laboratories and Manufacturing. This includes performing QA oversight, reviewing audit trails, approving CSV/Qualification documents for equipment (e.g., HPLC, GC, MES), and defining critical data flows to maintain QA integrity. You will also support KPI maintenance and act as an e-DI expert within the organization.
Key responsibilities:
Review and approve e-DI deliverables such as URS, FRA, and qualification reports in alignment with current guidelines.
Approve equipment qualification reports and audit trails according to GxP standards.
Perform electronic data reviews on manufacturing and QC laboratory equipment.
Simplify and streamline processes to remove obstacles and support continuous quality improvements.
Contribute to quality strategies ensuring data integrity for assigned projects.
Participate in the implementation of new e-DI SOPs and ensure compliance with GxP standards.
Enforce stakeholders' adherence to electronic data integrity processes.
Coordinate with internal and external stakeholders, including CMOs, to manage product-related deviations, change controls, investigations, and incidents.
Location: Bulle, Switzerland
Activity rate : 100%
Type of contract: Temporary contract
Start Date: 01.03.2025
End Date: 27.02.2026
On that role, you will ensure compliance with electronic data integrity (e-DI) processes in QC laboratories and Manufacturing. This includes performing QA oversight, reviewing audit trails, approving CSV/Qualification documents for equipment (e.g., HPLC, GC, MES), and defining critical data flows to maintain QA integrity. You will also support KPI maintenance and act as an e-DI expert within the organization.
Key responsibilities:
Review and approve e-DI deliverables such as URS, FRA, and qualification reports in alignment with current guidelines.
Approve equipment qualification reports and audit trails according to GxP standards.
Perform electronic data reviews on manufacturing and QC laboratory equipment.
Simplify and streamline processes to remove obstacles and support continuous quality improvements.
Contribute to quality strategies ensuring data integrity for assigned projects.
Participate in the implementation of new e-DI SOPs and ensure compliance with GxP standards.
Enforce stakeholders' adherence to electronic data integrity processes.
Coordinate with internal and external stakeholders, including CMOs, to manage product-related deviations, change controls, investigations, and incidents.
qualifications
What will make you successful:
Bachelor's or Master's degree with 5+ years of experience in the pharmaceutical industry, specializing in CSV, GMP-compliant equipment qualification, or QC laboratory operations.
Proven experience in QA, reviewing and approving qualification/CSV deliverables, with solid knowledge of LIMS, Empower, and lab equipment software.
Strong project management skills, meeting deadlines, and adapting to complex environments.
Fluent in French and English, with excellent communication, negotiation, and writing skills.
Creative, proactive, and adept at suggesting process improvements while maintaining discretion and trustworthiness.
You are interested in knowing our way of work, then check this url: https://tour.ucbsuisse.ch/fr
You are interested in knowing our way of work, then check this url: https://tour.ucbsuisse.ch/fr
informations de contact.
nous sommes à ta disposition pour toute question.
LS
Laetitia Stirer
Randstad UCB Bulle
procédure de candidature.
Découvre comment se déroule la procédure de candidature et comment nous pouvons t'aider à trouver un emploi.
1 de 8
postuler avec randstad.
Postuler avec nous, c'est facile. Nous examinerons ta candidature et verrons si tu corresponds au poste et à l'entreprise.
2 de 8
nous te contacterons.
Notre consultant t'appellera au moment qui te convient pour discuter de ta candidature et de tes aspirations professionnelles.
3 de 8
ton inscription.
Si tu n'as jamais travaillé avec nous auparavant, nous aurons besoin d'informations de base supplémentaires pour confirmer ton éligibilité à travailler en Suisse.
4 de 8
vérification des références et des antécédents.
Ensuite, nous devrons simplement vérifier quelques éléments – nous effectuerons les contrôles de conformité appropriés et te tiendrons informé.
5 de 8
L'emploi parfait pour toi.
Notre équipe d'experts organisera un entretien pour le poste pour lequel tu as postulé ou, si elle pense qu'il existe une meilleure opportunité, elle te proposera également des options alternatives.
6 de 8
Ton entretien.
Nous veillerons à ce que tu sois parfaitement préparé avant ton entretien et que tu saches exactement à quoi t'attendre – bonne chance!
7 de 8
Commence ton nouvel emploi.
Félicitations, tu es prêt à commencer ton nouvel emploi. L'équipe veillera à ce que tu sois parfaitement préparé pour ton premier jour.
8 de 8
soutien continu.
Après avoir commencé ta nouvelle mission, nous te contacterons pour avoir de tes nouvelles et t'apporter notre soutien dans ton nouveau rôle.
jobs par e-mail
Nous te tiendrons informé lorsque nous aurons des offres d'emploi similaires.
Merci de t'être abonné à tes alertes emploi personnalisées.
