Qc Analyst - Merseyside, United Kingdom - Adepto Technical Recruitment Consultancy

Adepto Technical Recruitment Consultancy
Adepto Technical Recruitment Consultancy
Verified Company
Merseyside, United Kingdom

1 month ago

Tom O´Connor

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Tom O´Connor

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Description
QC Analyst - Pharmaceutical - North West - Contract role
Job Summary

The purpose of the QC Analyst role is to compliantly perform QC laboratory testing, data review and data interpretation in accordance with approved Standard Operating Procedures (SOPs).

Analysis is performed on in-process, intermediate and finished vaccineproducts, raw materials, components and utilities samples.

QC Analysts are also required to participate in technical and validation studies in support of both departmental and site objectives.

Principal Accountabilities

  • The primary responsibility of a QC Analyst is to compliantly perform laboratory testing, data review and data interpretation in accordance with approved SOPs. It is expected that analysts consistently work to the highest standards of cGMP (as defined inthe EU GMP Annexes and FDA CFRs) and in accordance with the uppermost standards of HSE.
In addition to testing, Analysts will be required to perform raw material and components inspection (quality receipt) and sampling.

It is the responsibility of QC Analysts to communicate their findings as a result of testing promptly, to the QC Analytical leadership team (Team Coordinators and Manager).

Specifically, it is expected that deviations (either out of specification results orcompliance gaps) are highlighted to a leadership team member immediately as they are recognised.

It is the responsibility of QC Analyst, when assigned, to complete critical tasks such as:

  • Instrument Maintenance and Calibration
  • Reagent and Standard Qualification
  • Initiation of deviations
  • Initiation, and completion, of CAPAs
  • Completion of Change Control actions
  • Updates and reviews of SOPs
  • Participation in quality risk assessments
It is the responsibility of QC Analysts to participate in laboratory administration tasks such as:

  • HSE risk assessment completion, review and adherence
  • Archiving of laboratory documentation,
  • Ordering of reagents and consumables
  • Maintenance of QC sample and reagent stores
  • Ensuring a clean and safe workplace for all associates
  • It is the responsibility of QC Analysts to proactively maintain their own training records, and to only perform tasks that they have confirmed themselves to be compliantly trained in, in accordance with local SOPs
  • It is the responsibility of QC Analysts to ensure that they communicate professionally and effectively with their fellow team members and the QC Analytical leadership team.
Knowledge, Skills & Competencies
QC Analysts must be fluent in English as the primary operating and reporting language used within the industry, in addition they must:

  • Have experience in QC testing techniques appropriate to their role
  • Have an awareness of the requirements for equipment and method validation
  • Have awareness of root cause analysis
  • Be computer literate and be able to demonstrate an understanding of electronic systems
Minimum Education Requirements
QC Analysts must be educated to NVQ level 2 or equivalent in a relevant scientific discipline
Minimum Experience Requirements
QC Analysts must be have experience in the relevant testing discipline, ideally within the pharmaceutical industry having worked to cGMP standard
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