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Quality Specialist

  1. Cork
  1. Contract
Competitive
  1. Compliance / Quality Assurance
06-09-2023
31950
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Downstream Operations Administrator – Pharmaceuticals – Ireland

One of our global Pharmaceutical clients is looking for a Downstream Operations Administrator 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.

Essential Duties and Responsibilities for this role include, but are not limited to, the following:
  • Comply with our client and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions
  • Work collaboratively to drive a safe and compliant culture 
  • Perform quality function in Quality Risk Assessments as outlined in our clients procedures
  • Review and Approve system design documentation in area(s) of responsibility from a Quality perspective
  • Pre and Post Approve C & Q test documentation in area(s) of responsibility
  • Review and Approve validation summary reports supporting qualification
  • Ensure compliance to project C&Q leveraging strategy.
  • Complete all assigned training in a timely manner
  • Provide Quality support to offsite testing activities (FAT) as required.
  • Perform Quality function on all project change controls
  • Represent and fulfill the quality function at suite team meetings as required per area(s) of responsibility
  • Support the introduction of new products onto site in relation to Quality oversight, covering the end to end strategy.
  • Authors, reviews and participates in approvals of protocols and reports for technology transfer.
  • Review other documentation associated with new product introduction (QC Test Specifications, BOMs, MES documentation etc.)
Requirements:
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Knowledge of cGMP and GDP
  • Knowledge of Pharmaceutical manufacturing processes Report, standards, policy writing skills required
  • Equipment and process validation
  • Sterile filling processes and equipment
If you are interested, please apply now for more information!

The candidate must have the rights to work in the location stated in the job advert.

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