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Overview: We are seeking a highly skilled QA Coordinator to join our team. In this role, you will be responsible for coordinating and executing various activities across departments, managing key business deliverables, and ensuring process consistency.
Responsibilities:- Provide key support to the QA function within Stability Management, Material Management/Supply Chain and QA support.
- Coordinate the Stability Program-Management including study activations, creation and approval of stability studies. Receipt and activation of stability samples. Equipment monitoring 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 Batch Records, Cleaning Tickets and Logbooks
- 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.
- Site stability program coordination.
- Coordinate 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.
- A Level 8 degree in a relevant discipline (Hons BSc, MSc, Chemistry, Engineering, Quality, or other related discipline).
- 3 years' experience in the Pharmaceutical and Biopharmaceutical sector
- A minimum of 2 years Quality experience in a Pharmaceutical environment
- Ability to work on own initiative and to challenging schedules
- Excellent interpersonal and communication skills.
- Experience managing third party relationships desirable.
- Experience in document management.
- Experience with document management in the pharmaceutical sector.
- Excellent communication skills in English
- System experience is an advantage: SAP, Veeva Vault, Trackwise, Darwin, SuccessFactors, MS Word, Excel, Teams.
This role offers the opportunity to work in a dynamic environment and contribute to the success of our organization. We offer competitive compensation and benefits packages.
What We Offer:We are committed to providing a positive and supportive work environment that encourages growth and development. Our team is passionate about delivering exceptional results and making a meaningful impact.
How to Apply:If you are a motivated and experienced professional looking for a new challenge, please submit your application.