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QC Analyst

Posted on Oct 16, 2020 by Real Staffing Group

Dublin, Ireland
Research
Immediate Start
Annual Salary
Full-Time


THE COMPANY


Global pharmaceutical company with huge expansion plans based in Dublin is looking for a QC analyst to join their team in their brand lab.


JOB PURPOSE:


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.


RESPONSIBILITIES:


Quality Systems:



  • 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

  • Purchasing

  • Laboratory Auditing

  • LIMS data management and maintenance

  • Lean Laboratory Techniques


Analytical Testing:



  • 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


Validation:



  • 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.


EDUCATIONAL REQUIREMENTS:


Minimum of a BSc Degree (life science)


RELEVANT EXPERIENCE:



  • 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




Reference: 973436808

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