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Real Life Sciences

QC LIMS Analyst

Real Life Sciences

  • Dublin South
  • Not disclosed
  • Contract
  • Updated 07/12/2017
  • Samantha Kelly
this job is expired
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Description

My key client is currently under a massive expansion and is growing their current presence with the construction of a new standalone manufacturing facility dedicated to their oncology product.

 

My key client is currently under a massive expansion and is growing their current presence with the construction of a new standalone manufacturing facility dedicated to their oncology product.

They are global, research and development-driven pharmaceutical company committed to manufacturing life-changing medicines.

Role: QC LIMS Analyst

Contract: Hourly Rate - 12 Month contract

Location: South Dublin

Responsibilities

Quality Systems:

  • Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICHQ7.
  • 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.

Analytical Testing:

  • Provide expertise in a variety of analytical test procedures.
  • Carry out sampling and analytical testing of raw materials, packaging materials, intermediates and finished API product according to approved procedures and plant schedules.

Validation:

  • Carry out method transfer and method validation work as required, to meet project deadlines.
  • Review equipment qualification documentation for QC Laboratory equipment.

Good Laboratory Practices:

  • Ensure that Good Laboratory Practices are followed at all times.
  • Ensure that Analytical Method Worksheets are followed at all times.

General Responsibilities

  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values within the workplace.
  • Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Participate in the "Agile" programme.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

Experience Required:

  • 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 API facility, desirable but not essential.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP | Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Ref: RE-32761636_1511344641
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