Process Validation Specialist - Swisslinx
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Job Responsibilities
1. Design of the process validation strategy, preparation of validation documents (study design, writing protocols and reports).
2. Supporting R&D teams during the process characterization phase.
3. Reviewing and approving process characterization documents.
4. Responsibility for validation assessments on changes and deviations (approval of deviations and changes).
5. Preparation and maintenance of a detailed continued process verification plan.
6. Assessing and approving Product Quality Reviews.
Requirements
* Master's degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or equivalent.
* Experience in project management, preferably in Operations, MSAT, Quality, and Compliance.
* Experience interacting with different collaborators within an organization and with regulatory agencies (Swissmedic, FDA, etc.) is advantageous.
* Ability to manage multiple tasks simultaneously and meet deadlines.
* Proficient communication skills in English (written and spoken); proficiency in German is a plus.
Additional Details
* Seniority level: Entry level
* Employment type: Full-time
* Job function: Management and Manufacturing
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