QC Analyst

3 weeks ago

Dublin, Ireland Helsinn Birex Pharmaceuticals Ltd Full time

Laboratory Operations Analyst (QC Analyst)

(12-Month Fixed Term Contract)

Job Purpose:

The primary purpose of the Laboratory Analyst is to analyse raw material, in-process and finished product as well as stability samples according to the relevant specifications relating to development products while ensuring the documenting and reporting of same is conducted in accordance with good laboratory practices.

Key Responsibilities:

  • Working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP.
  • Receiving and logging samples into the Laboratory.
  • Analysing raw material, in-process, finished product and stability samples associated with development products according to specifications.
  • Performing analytical method validations and investigational testing as directed.
  • Recording results in a timely and accurate fashion.
  • Ensuring the Right First Time KPI with respect to Analyst’s documentation are achieved.
  • Reviewing co-workers/analyst documentation (i.e. Buddy System).
  • Ensuring that all Quality Systems within the department are adhered to on a daily basis.
  • Ensuring correct labelling of laboratory reagents and samples.
  • Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports).
  • Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance.
  • Training other laboratory staff as requested and appropriate.

Qualification / Experience / Skills:

  • A minimum of a BSc in a science related discipline.
  • At least one years' working experience within a cGLP Laboratory.
  • 12 month HPLC experience is a must.
  • Proven ability to troubleshoot, identify analytical issues and follow up with corrective actions.
  • Proven ability to critically review analytical data. Possessing excellent attention to detail is a must.
  • The ability to work well with all key contacts both internal and external to the organisation.
  • Experience working within a cGMP environment (HPRA and FDA approved) would be desirable.

Helsinn Birex Pharmaceuticals - we are a global pharmaceutical company and a leader in supportive care focused on improving the health and quality of life of patients with cancer and chronic diseases.

Skills:
GLP, GMP, HPLC, Dissolutions, GC

Benefits:
Performance Bonus, Parking Space with EV Charger, Health Insurance, Flex Time, Subsidized Canteen

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