In this role, you will play a key part in the integration of new raw materials into the QC Laboratory and lead method validation and specification setting. You will work cross-functionally with departments such as QC, Analytical Development, Regulatory Affairs, and Supply Chain, while reporting to the Senior Manager QC NPI.
Your main tasks
* Represent QC in cross-functional teams for New Product Introduction and raw material qualification
* Lead and support analytical method transfers, verifications, and validations
* Develop and write analytical methods, protocols, reports, and specifications
* Define and document incoming testing specifications for new raw materials
* Coordinate and evaluate testing of trial materials in collaboration with internal teams and external labs
* Support installation and qualification of new laboratory equipment and ensure proper training for QC staff
* Review compendial changes and manage related change controls in compliance with GMP standards
* Assist with resource planning and scheduling of incoming material testing activities
* Act as technical point of contact for raw material topics in the absence of the Senior Manager
* Promote continuous improvement initiatives within QC operations related to incoming material processes
Your profile
* Degree in Science, Chemistry, or similar field (CFC as Laboratory Technician or BSc level)
* At least 5 years of experience in a GMP-regulated environment
* Strong expertise in analytical method development, transfer, and validation
* Sound knowledge of regulatory compendia (Ph. Eur., USP, JP) and GMP requirements
* Practical experience with chromatography (HPLC, UPLC, GC) and classical wet chemistry techniques
* Proficient in scientific writing and GMP documentation (protocols, reports, procedures)
* Ability to troubleshoot analytical issues and support junior analysts when needed
* Detail-oriented, self-motivated, and able to manage multiple priorities independently
* Fluent in French and English, with strong communication and organizational skill
Domagoj Odrljin is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).
Full discretion is guaranteed and we will gladly answer any additional questions.
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