LSC have a great contract opportunity for a Senior Specialist, QC Quality Systems to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
* Lead and manage QC Investigations assigned
* Facilitate root cause analysis and problem solving sessions
* Complete the generation of associated investigation reports
* Determine and create CAPA's, Effectiveness Reviews, and Supplemental Tasks as required
* Present investigations at IRB to senior management
* Leading and coordinating the initiation, implementation, and closure of QC Change Controls
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* Education minimum of a B.Sc. Biochemistry or related discipline
* At least 3 years' experience, in a GMP laboratory setting ideally within a biologics laboratory
* A minimum of 1 years' experience with demonstrated effectiveness using quality systems (investigations/change controls - Trackwise/Infinity) in a FDA and EMA regulated environment
* Knowledge of biologics QC testing (Separations, Bioanalytical, Microbiology, Raw Materials and Stability testing) is desirable
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Siobhan Cummins on 021 4777329 if you have any more questions about this role!
