Senior Quality Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €62,000 - €88,000
About This Opportunity

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our quality assurance group, you will play a vital role in ensuring the accuracy and reliability of our laboratory systems.

  • This is an exciting opportunity for individuals looking to work in a top-performing company with a strong commitment to quality and excellence.
Main Responsibilities:

The Senior Quality Assurance Specialist will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems in a cGMP environment using CMMS Maximo.

  • Oversee tracking and management of activities through CMMS Maximo, author and approve validation life cycle documents for computer-related systems, ensure data integrity compliance and execute approved protocols.
  • Review and file QC calibration and maintenance documentation.
  • Qualify new laboratory equipment in a cGMP regulated environment by writing equipment validation protocols and associated summary reports.
  • Conduct periodic reviews of instrument validation as part of the validation life cycle.
  • Alert Quality Control Management if equipment fails to meet calibration or qualification requirements and conduct impact assessments/investigations as needed.
  • Schedule and coordinate equipment repairs and maintenance with vendors/contractors while minimizing downtime for lab equipment and disrupting laboratory activities.
  • Participate in technical project teams as a subject matter expert on instrument validation regulations and procedures.
  • Manage change controls and adherence to Change Control metrics where applicable.
  • Support and manage the addition of project components to CMMS Maximo.
  • Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
Requirements and Qualifications:

To be successful in this role, you will need:

  • A Bachelor's degree in a Science related field.
  • Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
  • Detailed knowledge of the methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
  • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
  • Demonstrated success in managing an equipment qualification or maintenance program is advantageous.
About Our Company

Our company is committed to delivering high-quality products and services to our customers. We value innovation, collaboration, and continuous improvement, and we are passionate about making a positive impact in our industry.

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