The Company

My client, a global leading Biopharmaceutical organisation, is looking for an experienced QC IS Specialist to join their large QC team and support the labs on site. This company have a large aseptic operations facility, specialising in secondary manufacturing activities - formulation, fill and packaging based in South Dublin. The site supports and enables the large-scale production of vials and syringes which contain treatment medication for oncology, rheumatology and other autoimmune illnesses. Their product portfolio currently sits at 10 and is ever growing in response to global health requirements.

The Role

This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to LMES/CIMS/EMpower and QC IS systems.

• Quality Control Business Owner and Laboratory Administrator for LMES (Accelrys LES, Accelrys IM), CIMS (Accelrys CIMS) and Waters Empower CD
• Manage and implement projects to maintain, develop and support lean laboratory practices such as review by exception, paperless lab systems SM- LIMS, Accelrys Smartlab (LES) and Accelrys CIMS (Inventory Management)
• Responsible for Computer System Validation within the QC laboratory to allow integration of laboratory instruments and systems to Smartlab (LMES)
• Deliver effective software support services to QC functions and liaises with Global teams and local IS.

The Person

The successful candidate will have:

• Hold a third level qualification in Science related discipline or IT/IS role
• Have a minimum 6 years' experience in Pharmaceutical or Biopharmaceutical Industry
• User Knowledge and experience with the following: Accelrys LES, Accelrys IM, Thermo LIMS and Waters Empower CDS is preferable
• Knowledge of Lab Operations, Analytical Lab Techniques, Commercialization, and cGMP and NPI advantageous

To discover more about this opportunity, apply now or contact Helena Boyle on (01) 6321870/0873360953 for a confidential discussion.