Stability Co-ordinator
About Chanelle Pharma:
This is an opportunity to be part of a dynamic team within the Quality function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
Reporting to the Stability Supervisor. The successful candidate will be responsible for supporting the Stability Program at Chanelle through interaction with multiple departments to ensure that the ICH requirements are met in regards Stability Testing and that all activities are compliant with regulatory guidelines, procedural requirements, and customer requests.
KEY RESPONSIBILITIES:
• Working with the Stability Supervisor to ensure that all product lines, both existing and new, are managed on the Stability Program as per international guidelines including planning, sample acquisition, creation of Protocols and Reports and scheduling of test activities.
• Co-ordination of Method Transfers from external sites to Chanelle’ s Laboratory and vice versa.
• To support the Stability Project Manager with on-going projects to increase efficiency within the Stability Program.
• To liaise with Planning to ensure Stability samples are taken appropriately as the schedule demands
• To liaise with Quality Control to ensure that all testing is performed within the test window
• To liaise with Chanelle Jordan to ensure that support is given from Chanelle Loughrea on all critical activities
• To assist the QC team in ensuring external samples are delivered to the correct locations
• To assist the QA department in compiling Product Quality Reviews and in answering customer queries
• To assist Customer Service in preparing quarterly invoices for customers charged for Stability activities.
• To assist the Registration teams in providing the necessary Stability data required for submission.
• To assist the Stability Project Manager with Investigations and Deviations as required, and the investigation of OOS results.
• To maintain the Stability Chambers and ensure all samples are stored as per the ICH requirements for their destination countries.
• To maintain the Stability Schedule and ensure all data is current, compliant, and updated when necessary.
• To assist the QC team in performing lab related activities when required,
• To monitor and review documentation, updating through Q-Pulse when necessary
• Any other activities as assigned by the Stability Project Manager.
If decided appropriate the above responsibilities may be amended or updated
COMPETENCIES:
• Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.
• Takes a methodical, systematic, and structured approach to organising work.
• Makes effective and consistent decisions in a timely manner.
• Takes personal responsibility for making a decision and taking action within their own area.
• Escalates issues appropriately.
• Displays flexibility, willingness to succeed and goes the extra mile. The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
QUALIFICATIONS:
•Bachelor’s degree in Science, Engineering, Technology or a related discipline.
•Experience working within a Pharmaceutical Laboratory, Quality Assurance or Regulatory Environment.
• Good grasp of the Microsoft Office Suite, in particular Microsoft Excel
• Displays a working knowledge of relevant pharmaceutical regulations including GMP, GLP and ideally ICH.
PHYSICAL DEMANDS: Health & Safety requirements (e.g., Manual Handling Training)
- Manual Handling
WORK ENVIRONMENT: (e.g., Office, Production)
- Lab
- Office
HOURS OF WORK
- 08:30 – 17:00 (Monday – Thursday)
- 08:30 – 16:00 (Friday)
