QC Stability Analyst
Liverpool (on site)
8:00 - 16:45 Mon – Thur 8:00 – 13:00 Fri
£16.31 PH
Start week commencing 31st May
CPL have teamed up with a market leading Pharma company who are looking for a Quality Control Stability Analyst to support all activities associated with product stability from study setup, monitoring, statistical analysis and report writing. The position will also supporting regulatory filings, and identifying issues/unexpected trends and offering advice/recommendations based on data obtained. To ensure delivery of a suitable stability programme in line with industry ICH guidelines
Responsibilities
· To author stability protocols, interim reports, and reports for stability studies. This includes routine campaign stability studies and non-routine project stability studies
· Management of stability studies in accordance with internal procedures, ensuring studies are set up per the protocol. Will liase with relevant QC laboratories to ensure stability samples are tested within their specified time frame.
· Trending of stability data through data table management and trend analysis utilising specialist software. To escalate any issues/trends to the QC Stability Team Coordinator and support any investigations as required. Will support the business in requests relating to stability data (including, but not limited to temperature excursion assessments, regulatory requests and investigational work).
· To own and support stability related Deviations, CAPAs and Change Controls, and progress department improvements as appropriate.
Knowledge and Skills Required
- Fluency in English
- cGMP background in the Pharmaceutical industry
- Experience of Quality Control testing techniques and industry practices
- Proven time management skills for planning and schedule of work
- Proven Communication skills both written and verbal.
- Strong Microsoft excel skills
- Analytical Mindset
· A level of statistical analysis experience is beneficial
Please apply within or send your CV to [email protected]