Posted on Oct 16, 2020 by Real Staffing Group
Global pharmaceutical company with huge expansion plans based in Dublin is looking for a QC analyst to join their team in their brand lab.
The QC Analyst has an important role to play in the start up of the Quality Control laboratory in a new manufacturing facility and the routine operation of the QC laboratory when start-up is complete. The QC Analyst will have specific and varying duties and some key tasks and responsibilities are outlined below. During start-up flexibility is important and responsibilities may change or other duties may arise.
- Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7A.
- Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications.
- Participate, as directed, in the following activities in the QC laboratory:
- Equipment Calibration
- Equipment Maintenance
- Reference Standard Management
- Laboratory Auditing
- LIMS data management and maintenance
- Lean Laboratory Techniques
- Provide expertise in a variety of analytical test procedures.
- Carry out sampling and analytical testing of raw materials, packaging materials, intermediates, Drug Substance and Drug Products according to approved procedures and plant schedules.
- Carry out sampling and testing of manufacturing facility cleaning samples
- Carry out sampling and chemical testing of manufacturing facility pure water samples
- Ensure that all testing information is recorded accurately and completely according to procedures.
- Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Senior/QC Executive so that corrective action may be taken.
- Provide assistance and guidance in deviation investigations, OOS investigations, and change proposals.
- Provide samples to contract testing laboratories and liaise with these laboratories as required.
- Familiarity with CDS and LIMS is desirable but not essential
- Carry out method transfer and method validation work as required, to meet project deadlines.
- Review equipment qualification documentation for QC Laboratory equipment.
- Participate in the cleaning validation programme.
Good Laboratory Practices:
- Ensure that Good Laboratory Practices are followed at all times.
- Ask, if in doubt, about any particular practice or unusual finding.
- As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.
Minimum of a BSc Degree (life science)
- A minimum of 3 years' work experience in a regulated GMP/GLP environment
- Practical experience with HPLC and GC systems
- Experience with writing and reviewing SOP's/validation protocols
- Experience with Method transfer/validation, desirable but not essential
- Experience working in an DS/DP facility, desirable but not essential
For immediate consideration apply with an up to date CV. Not sure yet? No CV ready? Get in touch for more information.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, United Kingdom | Partnership Number | OC387148 England and Wales