QA Assistant

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