About us
CARESILIUM est une société de conseils en ingénierie 100% suisse romand. Notre flexibilité, ainsi que les valeurs que nous portons : l'honnêteté, la franchise et la simplicité, nous permettent de créer des accompagnements sur mesures qui tiennent comptes de tous les besoins, les enjeux et les contraintes de nos partenaires. Une collaboration de confiance, c'est avant tout un recrutement bienveillant et transparent.
Avec CARESILIUM, rejoignez une équipe où vos attentes professionnelles ET personnelles sont au centre des décisions. Chaque parcours est accompagné individuellement par un manager technique qui saura vous guider vers votre but.
Et rappelez-vous toujours : chez CARESILIUM, notre plus belle valeur, c'est vous
Vous avez des questions ? Besoin de précision ? N'hésitez pas à prendre contact avec nous!
Job Description
The Quality Control laboratory performs analytical & microbiological testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing. Multiple method transfers and validations are performed to support new products.
This position is responsible for the Quality Control support activities, including the setup and maintenance of master data within LIMS, Empower and analytical instruments, setup and qualification of new instruments, audit trail review, and adherence with data integrity principles.
As a QC leader, you will be customer focused. Using your significant experience, you will mentor and coach your team, creating a strong team spirit. You will continuously improve processes to ensure they remain in compliance with cGMP, EHS and best practices.
Essential Job Functions:
Responsible for robust and effective QC support processes for the different phases of the life cycle (transfer, validation, clinical, commercial, etc.).
QC support processes include activities performed by your team, as well as other QC team members, and other departments.
Responsible that QC support processes comply with GxP.
Accountable that instruments, LIMS, Empower and computerized systems are set up and available for use. Working through your team.
Raising and managing change requests.
Participate in initial instrument qualification, responsible for Performance Qualification.
Responsible for instrument and system support documentation, including configuration specifications and SuperUser, User and IT procedures.
Set up master data in instruments, LIMS, Empower and computerized systems.
Accountable for master data management and audit trail review of LIMS, Empower & computerized systems.
Accountable for adherence with data integrity principles.
Responsible for continuing the high performance of your team.
Ensures continuous professional development and guidance to direct reports.
Team member backups and succession plans.
Day-to-day management (planning, communication, team organization, control & feedback).
Responsible for resolution of deficiencies linked to lab equipment, LIMS, Empower and computerized systems, assuring effective root cause identification and corrective/preventive actions. Initiates and manages related change requests, and ensures completion through to effectiveness check.
Required qualifications
Experience / Education
University studies in chemistry, biochemistry, pharmacy or equivalent
At least 5 years in Quality Control in a pharmaceutical company
At least 5 years managing teams
OSD and / or CMO experience highly advantageous
Knowledge / Skills / Abilities
Thorough understanding of cGMPs and their practical application in a QC laboratory at different phases of the life cycle (transfer, validation, clinical, commercial, etc.)
Solid knowledge of analytical technologies and laboratory workflows, such as HPLC, dissolution, Karl-Fischer, sampling techniques and workflows, etc.
Knowledge of electronic data lifecycle management in the laboratory to ensure data reliability and integrity
Familiar with laboratory investigation and establishment of corrective and preventive measures
Organized and rigorous
Demonstrated ability to lead and coach high performing teams to maintain an environment of trust and personal accountability
Strong communication skills with your team, peers, management and clients
Drives continuous improvement
Comfortable working daily in French and English (written and verbal)
