Operations Technical Specialist

  • Cork
  • Quanta Part Of Qcs Staffing
Operations Technical Specialist - Pharmaceuticals - Cork - 12-Month Contract One of our global Pharmaceutical clients is looking for a Operations Technical Specialist to join their team close to the picturesque and historical city of Cork. The site is renowned for manufacturing excellence and plays a vital role in the company's large-scale biotech operations worldwide. The site has received € million in investment over the last five years to continue the growth and expansion of the facility; with new products coming to the site, it is an exciting time to join the team. Bring energy, knowledge, innovation to carry out the following:Support the process including trouble shooting and leading SPS for issues that occur on the shop floor.Managing EHS and Quality investigations and overseeing batch record reviews.Provide technical support to Operation functions and changes.Lead cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT.Technical Report and investigation writing.Be responsible for the completion of continuous improvement projects to support manufacturing operations through the development of validation schedules, master plans and validation protocols.Be responsible for management and completion of Batch Record reviewsApply Lean Six Sigma and Lean methodologies.Represent the department on cross-functional project teams.Adherence to highest standards for Compliance (Quality and Safety).Ensure compliance with site EHS policy, cGMP and other business regulations and lead/co-ordinate Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.What skills you will need: In order to excel in this role, you will more than likely have:1-3 years’ experience as an operation role in a pharmaceutical or a highly regulated environment.B.Sc. Degree or other qualification in Biochemistry, Microbiology, Chemistry, Engineering or a related field.A working knowledge of the GxP systems associated with this role would be advantageous. These include, but are not limited to: GLIMS, eVAL, Delta V.Experience in Batch Record reviews.If this role is of interest to you, please apply now! #LI-JS5