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QC Analyst

QC Analyst -Pharmaceuticals – Dublin – Contract

The QC Analyst will be responsible for verifying the raw materials analytical methods and performing supplier qualification. This is an exciting opportunity to join a leading global pharmaceutical organisation. If you have 2 + years of experience in a pharmaceutical environment with experience working in a raw material lab and you're looking to join a growing, forward-thinking leader in the industry then please get in touch for more information.

Overview of Main Responsibilities (full job description available on request):

  • The candidate will have responsibilities in analytical transfer and qualification of methods.

  • Perform supportive activities for general lab readiness, laboratory equipment qualification and method transfers.

  • Perform and carry out a variety of routine analytical techniques including but not limited to HPLC, HIC, CE, IEX, HP-SEC, UV, pH, Colour, Osmolality, Degree of Coloration, and Appearance in compliance with GMP requirements.

  • Follow up-to-date analytical practices with reference to pharmacopeias, 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.

  • Solution preparation, cleaning, routine equipment maintenance, and system set-up.

  • 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.

  • Assist in training new QC Analysts on routine procedures and practices.

  • Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.

  • Responsible for driving a culture of Continuous Improvement by deploying company Six Sigma tools.

  • (This position will be on days with the possibility of shift work when required.)

What the ideal candidate looks like:

  • Degree qualification (Science/Quality/Technical). Master preferred.

  • 2 + years of industry experience with significant knowledge and experience in working in a Raw material lab unit and working with contract labs

  • Experienced in testing as per the pharmacopeia

  • Working knowledge of QC Systems (Empower, elogs, Electronic Lab Notebook, LIMS)

  • Preference Lean Six Sigma. 

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675