QA Assistant
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