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Avishek Singh
Life Science

00353872827991
[email protected]
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Details

QC Bioanalytical Analyst


Reference:AS23727 Location: Dublin North
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organisation based in Dublin.

The role will be responsible for performing analytical testing within the Biologics laboratory.

Duties:

  • Executing and Supporting routine analytical testing with assays such as HPLC Analysis (IEX, SEC, RPLC), UV analysis, Capillary Electrophoresis (CE), PCR testing, Bioassay methods (ELISA methods) and a wide range of compendial methods on Release, In-process, Stability samples in compliance with GMP requirements.
  • Executing and Supporting routine analytical testing with Raw materials onsite.
  • Follow up-to-date practices with reference to pharmacopoeias, specifications, regulations and industry standards.
  • Support the laboratory testing schedule to achieve an efficient QC system.
  • Receive and manage samples that come into the lab for stability, in-process and release testing.
  • Calibrate and maintain all designated laboratory instruments.
  • Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.
  • Maintain data integrity and ensure compliance with company SOPs, specifications and cGMP regulations.
  • Ensure that cGMP standards are maintained at all times.
Education and Experience:
  • 1 - 5 years laboratory testing experience in the Pharmaceutical or Biopharmaceutical industry.
  • Qualification in Science/Chemical Engineering/Biological Engineering.
  • Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing, chemistry testing and raw material testing.
  • Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices.
  • Knowledge of cGMP & Laboratory Quality Systems.
If interested in this posting please feel free to contact Avishek Singh at [email protected] or 0872827991 for further information.