This 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.
As a QC Stability Coordinator, you will be responsible forCollaborating 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.
Coordinating Method Transfers between external sites and Chanelle Pharma's Laboratory.
Supporting the Stability Project Manager in improving efficiency within the Stability Program.
Liaising with Planning to ensure timely stability sample collection as per schedule.
Working with Quality Control to ensure all testing is conducted within the required time frame.
Coordinating with Chanelle Jordan to provide support for critical activities at Chanelle Loughrea.
Assisting the QC team in ensuring external samples reach the correct locations.
Supporting the QA department in compiling Product Quality Reviews and addressing customer queries.
Assisting Customer Service in preparing quarterly invoices for Stability-related charges.
Providing Stability data for submission to the Registration teams.
Supporting the Stability Project Manager with Investigations, Deviations, and Out-of-Specification (OOS) result investigations.
Maintaining Stability Chambers, ensuring samples are stored as per ICH requirements for destination countries.
Updating and maintaining the Stability Schedule, ensuring compliance and accuracy.
Assisting the QC team in laboratory-related activities as required.
Monitoring and reviewing documentation, making updates through Q-Pulse when necessary.
Performing any other duties as assigned by the Stability Project Manager.
Experience & EducationBachelor's degree in Science, Engineering, Technology, or a related discipline.
Experience in a Pharmaceutical Laboratory, Quality Assurance, or Regulatory Environment.
Working knowledge of relevant pharmaceutical regulations, including GMP, GLP, and ideally ICH.Skills & CompetenciesProficiency in Microsoft Office Suite, particularly Microsoft Excel.
Ability to take direction and seek clarification when needed.
Strong interpersonal skills, building effective working relationships and contributing to a cohesive team environment.
Development of technical skills with a methodical, structured approach to work.
Effective prioritization of tasks and the ability to differentiate between urgent and non-urgent decisions.
Ability to escalate issues appropriately when required.
Demonstrates flexibility, willingness to learn, and a proactive approach.
Displays accountability, initiative, and problem-solving skills.