LSC has an exciting opportunity for a QA Assistant to join a pharmaceutical company in Limerick. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- 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, study sample inventory, equipment monitoring, manage stability samples, approval Stability Study Reports.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Working with the Annual Stability Sampling Plans ensuring oversight stability sample management.
- 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.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Grainne Hodnett at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert