QC Analysts

QC Analyst
Dublin, Tullamore
Posted 2 months ago

The Role

These QC Analysts roles will be predominantly based in Dublin. However where support in our Tullamore facility is required the successful candidate will be expected to work there. These roles are initially 12 month contract positions with the possibility of contract extension.

Principle Duties

The successful candidate will be involved in :

  • Analysis of IMP/GMP Material/Product including Stability Samples using the following techniques: HPLC (Assay, CU, Related Substances, Cleaning samples) Dissolution Spectrophotometry (FTIR) Karl Fischer Physical Testing Wet Chemistry Techniques
  • Analysis of samples relating to investigations, cleaning verification and development.
  • Troubleshooting of analytical equipment and methods.
  • Perform validation/verification of analytical test methods.
  • Write validation/verification protocols and reports for analytical test methods.
  • Write stability protocols and reports to support stability program.
  • Perform peer review of analytical data, electronic data, protocols, reports etc.
  • Support Analytical Change control, CAPA and Deviation Management.
  • Support Analytical equipment calibration maintenance and management.
  • Write and update Analytical documents as required (SOP’s, Test Methods etc.)
  • Participate in deviation root cause analysis investigations, risk assessments and impact assessments for the Analytical laboratory.
  • Support the management and administration of outsourced and internal starting material analysis.
  • Management and administration of Analytical laboratory systems e.g. Reference standards, Retains, Stability.
  • Communicate progress on actions to Analytical Development & QC Manager and to project team.
  • Support audit preparation activities.
  • Train and support new analysts.
  • Participate in team meetings and work according to agreed timelines.
  • Work in accordance with cGMP (where appropriate) and Sublimity Therapeutics procedures.

Minimium Requirements

  • Educated to degree level in a Science Discipline (Chemistry, biology etc.)
  • Strong knowledge of GMP & GLP requirements.
  • Good working knowledge of Microsoft Word, Excel, PowerPoint.
  • Willingness to learn and ability to adapt to the needs of a busy lab.
  • Good interpersonal and team working skills.
  • Strong written and verbal communication skills.
  • Demonstrates a positive attitude to work and uses time efficiently and effectively.
  • Minimum 6 months experience in a pharmaceutical laboratory environment (intern placement adequate).

Desirable Skills

  • MSc in Analytical Science, Pharmaceutical Science or related discipline.
  • Analytical Science and instrumentation to have been significant components in undergraduate degree.

Experience with statistical analysis or statistical software (e.g. Minitab)

How to apply

Suitable Candidates should submit a CV and cover letter by close of business, December 9th, 2019 to careers-irl@sublimitytherapeutics.com

The salary is negotiable and dependant on the experience of the successful candidate.

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