Qc Team Leader - Morpeth, United Kingdom - Science Solutions Recruitment Ltd
Description
QC Team Leader - Pharmaceuticals - Northumberland
An established Pharmaceutical CDMO in the North East are currently looking to add a QC Team Leader to their team, primarily responsible for leading a team of analysts testing products using HPLC, GC, UV-vis along with leading investigations of OOS/OOT resultsand assisting with providing training/mentorship to other analysts.
As a QC Team Leader you will have prior industrial experience with Pharmaceutical QC Analysis along with method validation experience in accordance with ICH guidelines and QA experience in line with cGMP standards and prior experience lead a team of Analysts.
Responsibilities
- Perform analysis on raw materials, inprocess, finished products and stability samples using various analytical techniques including HPLC, GC and UVvis.
- Preparation and completion of GMP related documentation (SOPs, batch records, etc.)
- Investigate any deviations, identifying the Root Cause and implement relevant change controls, CAPAs
- Validate new and existing methods in accordance with ICH guidelines
- Lead a team of 5 Analysts, assigning work loads, reviewing results and identifying training requirements where appropriate
Requirements:
- Significant practical experience with HPLC, GC and wet chemistry techniques is essential
- Prior experience with QA based activities including deviations, change controls, CAPAs, authoring and reviewing documentation is essential
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