Quality , Science, Pharmaceutical & Food

QC Analyst – Carlow

  • Contract
  • Remote
  • Carlow
  • 41934683

PE Global are recruiting for a QC ANALYST -SHIFT on behalf of our Bio client site in Carlow:

 

QC Analyst Chemistry–  11  Month initial contract – 2 cycle shift Morning (7am -3pm Mon-Thu , 7am-2pm Friday ), Evening (3PM-11PM Mon-Thu, 2pm-9pm Fri). 2 open roles here.

The QC Analyst will report directly to the QC Chemistry Manager and will help us to complete analytical method transfers and validation as well as routine testing.

Our Quality Operations Laboratory team is growing, and we are interested in you! At this time, the team is working a shift pattern and may divert back to day hours in the coming month, so flexibility at this time is an ask!

2 Cycle Shift

Morning (7am -3pm Mon-Thu, 7am-2pm Friday)

Evening (3PM-11PM Mon-Thu, 2pm-9pm Fri).

 

Role Functions

(Functions include, but are not limited to, the following)

  • Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
  • Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
  • Operate as part of the QC team performing the allocated testing and laboratory based duties.
  • Perform various analytical techniques including but not limited to HPLC/UPLC, (HIC, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements
  • Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
  • Participate in the laboratory aspects of OOS investigations.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  • Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc,
  • Work collaboratively to drive a safe and compliant culture in Carlow.

 

Experience, Knowledge & Skills

  • 2-3 years of experience in a pharmaceutical laboratory.
  • A good working knowledge of HPLC systems and software is desirable.
  • A good knowledge of cGMP, GLP, Quality Management Systems.
  • Method validation and method transfer experience would be Advantage.

 

Initial Travel Requirements:

  • Occasional travel may be required for training purposes.

 

Qualifications & Education

 

  • Bachelors’ Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline

 

Please click the link below to apply, call Audrey on 021- 4297900 or alternatively send an up to date CV  Audrey.mccarthy@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

  

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