Overview
Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.
Are you passionate about quality and interested in GxP environments?
Join a team where your quality skills will make a real impact on patients\' lives.
In order to continue to successfully support our clients, we are currently looking for a QA / QC Specialist with solid experience in GMP environments to support manufacturing operations, batch release, and continuous improvement of quality systems to work in Switzerland Lausanne area:
About the job:
QA Responsibilities
* Manage deviations, CAPAs, Change control, and ensures the execution and the follow up of escalation processes
* Review batch records for product release.
* Actively participate in internal audits and regulatory inspections (EMA, FDA, etc.).
* Write, update, and validate SOPs and quality documentation.
* Handle change controls and support qualification/validation activities (DQ, IQ, OP, PQ, cleaning validation, process validation) for QA review.
* Provide GMP and procedural training to staff.
* Supports QC/QA transfers of new products/methods ..
QC Responsibilities
* Perform or supervise physico-chemical and/or microbio testing.
* Monitor stability studies in compliance with guidelines.
* Oversee laboratory equipment (qualification, maintenance, calibration).
* Contribute to the implementation and improvement of analytical methods.
* write protocols and reports for validation and transfer of analytical methods
* realize validations and transfers of analytical methods
About you
* Experience of minimum 3 years in Quality Assurance / Quality Control in a pharma or biotech company.
* Master Degree (or equivalent) in Life Sciences or a related discipline.
* Thorough understanding of cGMPs, Eudralex, GLP and FDA 21 CFR regulatory requirements.
* Excellent written & oral communication skills.
* You have good analytical, organizational, time management and problem-solving skills.
* French with good knowledge of English
About us
* We are a Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
* We do care about our people, communicate openly and value feedback
* We work as a team where every member is valued and appreciated
* We offer the opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
* We propose continuous learning and development opportunities via internal or external training and workshops
* We offer a competitive salary package in line with industry practice together with exceptional employment benefits
At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!
If you also share the same passion and values, we will be glad to hear from you! Please send us your application.
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