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.