Key Responsibilities:
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* Site Stability Program Coordination
* Coordinating with laboratories to ensure stability sample pulls are performed within the outlined pull window and aligning this with the lab's requirements.
* Participating member of a New Product Introduction team, responsible for product stability requirements, including stability cabinet/storage capacity, stability simulator, stability specification, and time-point requirements.
* Study management for Stability program lots, study timepoint pulls, completion of Stability Studies, flagging batches, registering parent lots, and completing Study Activation and Receiving Stability Parent Samples.
* Development of Study Lot Details and creation of Graphics on Darwin Stability Program.
* Study completion and notification to management for final approval.
* Maintenance of materials management and supply chain responsibilities.
* Creation of Certificates of Analysis and Certificates of Compliance for weekly Shipping using various systems and reports, working with Shipping schedules.
* Supporting QA team to ensure Non-Routine Certificate of Analysis are maintained.
* Perform COA compliance checks for Consumables and raw materials.
Job Requirements:
* Hons BSc, MSc, Chemistry, Engineering, Quality, or related discipline, with a minimum of 2 years relevant experience.
* Excellent communication skills in English.
* System experience is an advantage: Veeva Vault, Trackwise, Darwin, SuccessFactors, MS Word, Excel, Teams.
About Us:
We champion diversity and equality, anchoring our workplace cultures and creative minds. We recognize the collective strength found in the diverse backgrounds, skills, and experiences of our team members. Our commitment to fostering an inclusive environment transcends gender, marital status, family status, age, disability, sexual orientation, race, religion, and membership in the Travelling community.
For more information, please feel free to reach out.