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Senior QC Analyst - Ireland  

Company managed [?] Still accepting applications

Posted on : 29 March 2017

Project Description



Description:
  • The QC Senior Analyst  will work in the Quality Control Laboratory in our company.
  • The QC Senior Analyst has an important role to play in the start-up of and the routine operation of the P2 QC laboratory.  
  • The QC Senior Analyst will have specific and varying duties. 
  • Some key tasks and responsibilities are outlined below. 
  •  Flexibility is an important attribute as responsibilities may change as 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 Q7.
  • 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
    • Purchasing
    • Laboratory Auditing
  • LIMS data management and maintenance



Validation:
  • Lead method transfer and method validation projects as required.
  • Prepare and review equipment qualification documentation for QC Laboratory equipment, including data integrity requirements.
  • Participate in the cleaning validation programme at the TILGC facility, including development of analytical methods as required.



Analytical Scheduling / Review:
  • Provide expertise in a variety of analytical test procedures.
  • Review all analytical data in a timely manner with a high attention to detail.
  • Plan and prioritise scheduling tasks for other analysts within the QC laboratory.
  • Carry out sampling and analytical testing of raw materials, packaging materials, intermediates, API and finished drug product according to approved TIL GC procedures and plant schedules, when required.
  • Ensure that all testing information is recorded accurately and completely according to TIL procedures.
  • Ensure that any deviations or out of specification (OOS) results are reported immediately to the QC Executive so that corrective action may be taken.
  • Provide guidance in deviation investigations, OOS investigations, change proposals and batch disposition.
  • Lead investigations where necessary.
  • Provide samples to contract testing laboratories and liaise with these laboratories as required.
  • Ensure analysts are adequately trained as per TILGC SOP’s.



Good Laboratory Practices:
  • Ensure good Data Integrity practices are maintained and followed at all times.
  • Ensure that Good Laboratory Practices are followed at all times.
  • As a member of the quality function, work with other departments to promote a culture of compliance to Good Manufacturing Practice within the plant.



QualificationsEDUCATIONAL REQUIREMENTS:  
Minimum of a BSc Degree (life science)



RELEVANT EXPERIENCE:
  • A minimum of 5 years’ work experience in a regulated GMP/GLP environment
  • Experience of leading other QC analysts and scheduling daily activities
  • Experience troubleshooting QC methods
  • Practical experience with wet chemistry methods
  • Experience with writing and reviewing SOP’s / validation protocols / reports
  • Experience with Method transfer / validation is essential
  • Experience working on cross functional teams



SKILLS/COMPETENCIES:
  • Excellent organisational, communication, interpersonal and report writing skills
  • Demonstrable experience motivating and leading a team of Analysts
  • Ability to adapt to changing priorities


Schedule
Full-time