Description
Pharmaceutical company based in North Dublin is looking for a Senior QC Data Coordinator (R&D) to join their team for a 6 month contract.Reporting to the Head of Analytical the successful candidates day to day activities will include:
-Carry out Analytical reviews of development and QC Analytical test data
-Statistical treatment and interpretation of analytical data, preparation of analytical summary reports
-Responsibility for change control within the analytical laboratory
-Responsibility for deviations within the analytical laboratory
-Perform deviation root cause analysis, investigations and impact assessment for the analytical laboratory
-Write and update Analytical documents as required (SOP's, WI's, and Test Method)
-Write validation/verification protocols and reports fro analytical test methods and equipment
-Participate in analytical troubleshooting, OOS investigations and method development brainstorming.
-Communicate any concerns with GMP, safety or systems to relevant personnel.
-Train and support new analysts.
-Be involved in Audit preparation and follow up
-Perform validation/verification of analytical test methods and equipment
-Carry out analysis of GMP materials/products using the following techniques HPLC, Dissolution, IR Spectrophotometry, KF titration.
-Analyse samples relating to investigations, development and stability
-Comply all site-wide procedures and practices e.g. Safety, GMP
-Share and keep updated on technical pharmaceutical knowledge
Requirements:
-Degree in a relevant scientific discipline e.g. analytical, chemical and pharmaceutical sciences or other appropriate discipline
-Minimum of 5 years working in the pharmaceutical industry in Analytical development/QC or QA roles. Preferentially with IMP experience
-Excellent technical writing skills and attention to detail.
-Experience managing deviations and change control system would be advantageous.
If you are interested in this great opportunity and have the appropriate skill set and experience please contact me Anna Mooney .