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Operations Technical Specialist

  1. Cork
Cork
  1. Contract
Competitive
  1. Life Sciences
34217

This vacancy has now expired

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 €130 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 reviews
  • Apply 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! 

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