QC Analyst

The QC Analyst will participate as an active and flexible Quality department team member to provide a Quality Control service for the Endeavour Supply Chain Organisation.

 

Key responsibilities

  • Sample and test all incoming raw materials according to in-house specifications and methods of analysis.
  • Sample and test all incoming packaging components according to approved in-house specifications.
  • Test all finished products according to approved in-house specifications and methods of analysis including Spatone as required by the approved SOP.
  • Microbiological testing of raw materials, bulk and finished products, including Spatone as required by the approved SOP.
  • Environmental monitoring.
  • Maintenance of microbiological and environmental records and supply of related reports as necessary.
  • Microbiological method evaluation and validation.
  • Ensure that all laboratory tasks performed are in keeping with Good Laboratory Practice and that production processes adhere to the principles of Good Manufacturing Practice.
  • Carry out line checks on production activities and perform the relevant in-process checks, ensuring that such activities are in compliance with Good Manufacturing Practice.
  • Perform analyses, examinations or investigations as required on behalf of the Company.
  • Supply written reports as necessary on request.
  • Ensure all data is stored and entered in the correct file and that any test OOS are investigated via the OOS procedure.
  • Ensure all required retained samples are kept and stored correctly.
  • Contribute to the investigation of customer complaints as required.
  • Ensure that all chemical and consumable supplies are maintained.
  • Ensure that the laboratory is maintained in a clean and tidy condition, including the removal of laboratory waste.
  • Liaise effectively with staff from other departments.
  • Involvement in other QMS responsibilities as required as part of personal development.

 

Person Specification

Education / Qualifications

  • Educated to degree level or above in a Science subject

Skills and Experience

Essential

  • Experience in an analytical laboratory
  • Ability to use work instructions and specifications for testing of products, raw materials and components
  • A good appreciation of Good Laboratory Practice
  • Strong report writing skills
  • A good level of wet/bench chemistry skills
  • Experience or knowledge of HPLC and GC techniques
  • Experience of working in a regulated laboratory environment

Desirable

  • Experienced in the use of pharmacopeia’s Experience or knowledge of TLC techniques
  • Knowledge of ERP systems such as SAP
  • Experience of pharmaceutical production processes for tablets, liquids and creams
  • Basic knowledge of microbiology

 

Behaviours

  • Good attention to detail
  • Practical and organised approach