The role involves conducting activities within the Stability Team while ensuring compliance with GMP, Health and Safety, SOPs, environmental, and regulatory requirements.
The position also requires providing technical support as needed by management while ensuring customer needs are met.Key ResponsibilitiesCollaborate with the Project Manager to manage all product lines in the Stability Program as per international guidelines, including planning, sample acquisition, protocol/report creation, and scheduling of test activities.Coordinate Method Transfers between external sites and Chanelle's Laboratory.Support the Stability Project Manager in improving efficiency within the Stability Program.Liaise with Planning to ensure timely stability sample collection as per schedule.Work with Quality Control to ensure all testing is conducted within the required time frame.Coordinate with Chanelle Jordan to provide support for critical activities at Chanelle Loughrea.Assist the QC team in ensuring external samples reach the correct locations.Support the QA department in compiling Product Quality Reviews and addressing customer queries.Assist Customer Service in preparing quarterly invoices for Stability-related charges.Provide Stability data for submission to the Registration teams.Support the Stability Project Manager with Investigations, Deviations, and Out-of-Specification (OOS) result investigations.Maintain Stability Chambers, ensuring samples are stored as per ICH requirements for destination countries.Update and maintain the Stability Schedule, ensuring compliance and accuracy.Assist the QC team in laboratory-related activities as required.Monitor and review documentation, making updates through Q-Pulse when necessary.Perform any other duties as assigned by the Stability Project Manager.Competencies & Key BehavioursTakes direction and seeks clarification when needed.Builds strong working relationships and contributes to a cohesive team environment.Develops technical skills and applies a methodical, structured approach to work.Effectively prioritizes tasks and differentiates between urgent and non-urgent decisions.Appropriately escalates issues when required.Demonstrates flexibility, willingness to learn, and a proactive approach.Displays accountability, initiative, and problem-solving skills.Experience, Education & SkillsBachelor's degree in Science, Engineering, Technology, or a related discipline.Experience in a Pharmaceutical Laboratory, Quality Assurance, or Regulatory Environment.Proficiency in Microsoft Office Suite, particularly Microsoft Excel.Working knowledge of relevant pharmaceutical regulations, including GMP, GLP, and ideally ICH.