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
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Job Description
Job Summary:
The Continuous Improvement and Compliance Senior Specialist is responsible for driving process improvements and ensuring regulatory compliance within the pharmaceutical industry. This role involves analyzing existing processes, identifying areas for improvement, and implementing best practices to enhance operational efficiency while maintaining adherence to industry regulations.
Essential Job Functions:
The Continuous Improvement and Compliance Senior Specialist is responsible for the following tasks and responsibilities:
• Process Improvement for Bulk, Packaging and Warehouse:
o Collaborate with cross-functional teams to identify opportunities for optimization,
o Develop and implement strategies for continuous improvement, using methodologies such as Lean or Six Sigma.
o Author and/or review production documents, including working practices, protocols, master batch record and follow up approval flow within electronic documentations system.
• Project Management:
o Lead and participate in cross-functional projects aimed at enhancing operational performance and compliance.
o Initiate, own, and follow up change controls related to manufacturing or warehousing. Manage stakeholders involved.
• Regulatory Compliance
o Ensure that all processes and practices comply with relevant pharmaceutical regulations and standards (e.g., FDA, EMA).
o Train the operational team to the procedures/protocols as required
o Initiate deviations and participate to, or lead on the floor complex investigations. Partner with QA, Warehouse, Packaging and Bulk Operations to ensure assessments and investigations are exhaustive.
o Follow up and implement assigned CAPA's.
Required qualifications
Job Requirements:
Experience / Education
• BS/MS in Engineering/Technical discipline or equivalent experience
• 5 years' experience in pharmaceutical validation, production, packaging or related field
Knowledge / Skills / Abilities:
• Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP
• Knowledge of pharmaceutical facilities, manufacturing systems and processes.
• Well-developed ability to constructively work across functional areas and levels to achieve results,
• Strong verbal and written communication skills,
• Strong analytical, problem solving, influential and deductive skills,
• Capability to work with short deadlines and simultaneous activities,
• Excellent organizational and project management skills,
• Fluent in English and in French.
