9184
QC Stability Specialist
Waterford, Ireland
Life Science
Fix Term Contract
9184
Posted on:
September 9, 2024
The Highlights:
- Joining a well - established team
- Great Workculture and Approachable management
- Working with clinical and commercial products
The Role:
Elusav recruitment have an excellent opportunity for a QC Stability Specialist with a leading Global Pharma and Biopharmaceutical company based in Waterford.
As the QC Stability Specialist you will manage stability programs including generation of protocols and reports, sample management, compilation of results and communication to both internal and external stakeholders.
Job 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).
Job Requirements:
- 3+ years' QC experience (Preferably in Pharma).
- Minimum of Bachelor's Degree in relevant scientific discipline.
- Experience in review of stability, PQR and trending related procedures preferred.
If you would like to learn more about the vacancy, apply now, or contact Stephen O'Brien on stephen@elusav.com or +3536959993.
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QC Stability Specialist
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