Job Description
A QC Stability Specialist is required by CareerWise Recruitment for our Waterford-based Biopharmaceutical Client for a 12-24 month contract.
Role of this position
*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
*A third level qualification of a scientific/technical discipline is required.
* 2-3 Years Experience Required.