Job Description
- Provide key support to the QA function within Stability Management, Material Management/Supply Chain and QA support.
- Co-ordination of the Stability Program- Management including study activations, equipment monitoring, stability study approval, activation and receipt of stability study samples and stability unit trend reviews.
- Responsible for the Packaging /preparation of the Product in the Laboratory.
- Responsible for quality-related matters specific to area of responsibility, including any Deviations and associated Investigations
- Generation of Certificates of Analysis/ Conformance to support shipping requirements.
- QA review of laboratory notebooks and logs.
- Assist with reconciliation of laboratory notebooks as required.
- Carry out day to day activities in compliance with site safety policy and procedure. Promote and encourage safe practices and promptly report any safety concerns.
- Provide back up for specific QA Assistant activities as required
- Work effectively within the QA function to deliver on objectives
Key Responsibilities:
- Site stability program co-ordination.
- Co-ordinate with labs to ensure stability sample pulls are performed within outlined pull window and align this with the lab.
- Participating member of a New Product Introduction team of the product’s stability requirements, e.g., 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. Flag the batch, Register the Parent lot and complete Study Activation, 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
- Monitoring stability units –alarm response, review of temperature/ humidity trends to ensure alarm response/ deviation are complete.
- Materials Management/Supply Chain
- Creation of Certificates of Analysis and Certificates of Compliance for weekly Shipping using various systems and reports, working with Shipping schedule.
- Supporting QA team to ensure Non-Routine Certificate of Analysis are maintained
- Perform COA compliance checks for Consumables and raw materials.
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
Feel free to reach out to [email protected] for a discussion on this role.
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