QC Stability Specialist

QC Stability Specialist

Contract: 23 month contract
Hours: Full-time, Monday to Friday - Hybrid
Salary: To be discussed
Location: Co. Waterford

Responsibilities:

• Management of stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders.
• Trending and statistical analysis of stability and release data for quarterly reports and Periodic Product Reviews (PPRs)
• Raising and on time closure of Stability, PQR and trending related Quality System records including assigned Change Controls, Deviations, CAPAs, ILIs & QEs
• Procedure effectiveness and simplification and actively contribute to continuous improvement initiative utilising lean methodologies where appropriate.
• Ensure effective co-ordination and support for external and internal audits for the department.
• Perform critical / constructive review of Stability, PQR and trending related procedures and practices.
• Identify and lead projects to make step change improvements to the department's Quality.
• Conduct duties in a safe manner and report all safety issues or concerns Support leadership team in achieving goals/ tasks Liaise with Quality assurance Representative to support and improve RFT in the area and Always Audit Ready
• Ensure all required training is completed on time
• Maintain training in critical test activities as required in the laboratory (will be defined by head of QC)

Skills & Knowledge:

• A third level qualification of a scientific/technical discipline is required.

If you hold a VALID WORK PERMIT for IRELAND. we would love to hear from you, if however, you do not hold a valid work permit for Ireland unfortunately we will not be in a position to assist you with your job search with regard to this role.

Contact: Louise Catherine Kelly | [email protected]