QC Compliance Analyst

  • Cork
  • Permanent
  • JO-1710-62945_1508764637

Summary

Responsibilities:

  • Perform analytical techniques in the area of Chromatography (HPLC, GC, TLC), spectroscopic methods (IV, UV) and wet chemistry techniques;
  • Assure the right communication channel with the production areas in order to give the best response to the requests;
  • Meet all GMP requirements as well as the Safety, Environmental and Health Regulations.
  • To maintain all laboratory notebooks, records, chromatograms to an acceptable GLP standard.
  • To maintain good housekeeping and hygiene within the laboratory.
  • To maintain and follow all relevant Standard Operating procedures.
  • To calibrate and maintain designated laboratory instruments.
  • To support the laboratory testing schedule in order to achieve an efficient QC system.
  • Support QC Lab Investigation Reports and Deviations.
  • Report on the timeliness of compliance to set timelines on LIR's, Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
  • Support the internal Compliance Programme within the QC department.

Requirements:

  • BSc in Scientific discipline
  • 3-5+ years minimum work experience in the pharmaceutical industry
  • Pharmaceutical experience in a GMP regulated laboratory environment
  • Good communications skills
  • Flexibility is essential (willingness to work shift patterns as required by business needs)
  • Proven ability to work on own initiative
  • PC skills MS Word, Excel etc.
  • Proven technical ability in laboratory systems.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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