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Regulatory and Quality - Quality Assurance/ HSE
Ref: 1063 Date Posted: Tuesday 07 Aug 2018
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Entrust People are recruiting for a highly organised and detailed orientated individual, with an ability to accurately and efficiently manage and maintain important documentation and data.   In this role, you’ll prepare and review Device Batch records for final release to stock and you will act as the custodian of the  Manufacturing records, specifications and design verification. You will also conduct and record internal audits as required.

Competences and Responsibilities

  • You’ll be able to identify and be responsible for achieving personnel training standards required by a QA Document Controller.
  • You’ll be responsible for signing off and circulate reports and SOPs in a professional and timely manner.
  • You’ll be responsible for monitoring and managing communication around the 2-year review of  QPs in advance of their deadline.
  • You’ll ensure that pre-defined company metrics are regularly updated and progressed to meet timelines.
  • You’ll be able to maintain document registers and issue document numbering accordingly (e.g. QP’s CAPA and Change Control requests).
  • You’ll be able and responsible for highlighting to the Quality and Regulatory Manager when document archiving is due.
  • You’ll be able to deputise on agreed aspects of the QMS for the Quality Manager when required.

General Tasks of the Role

  • General circulation for sign off and filing of original QA documentation as required in the relevant folders.
  • Archiving and ID of obsolete documentation.
  • Document manipulation using Microsoft word and Excel, e.g. turning forms into ‘Microsoft Templates’ and using conditional formatting on Excel to enhance QA spreadsheets.
  • Reminding colleagues of due dates for sign off/review of QA documentation.
  • To undertake any other duties as requested by the Quality Assurance and Regulatory Manager accordance with Company requirements

Qualifications and Experience

You’ll have the following qualifications and experience:

  • At least HND level and in appropriate area (Administration, Document Control, etc.)
  • At least 3 years of experience within a metrics driven, document controlled environment (preferably manufacturing).
  • Experience of handling and maintaining auditable documents
  • Attending and taking part in audit preparations.
  • Process work to ISO 9001 standards.
  • Experience of compiling data reports using Microsoft Excel graphical representations.
  • Experience in document design and preparation of templates.

You will have some or all of the following experience:

  • Understanding of Quality Systems in a Regulated Environment.
  • Work experience in regulated manufacturing environment
  • Experience of Medical Devices or Life Sciences.
  • Audit experience to at least 9001.
  • Report writing.

You’ll be competent in the following software:

  • Microsoft Excel-intermediate level (e.g. Conditional formatting/formulas).
  • Microsoft Word-intermediate level (e.g. use of design tools)
  • Microsoft PowerPoint-intermediate level (e.g. Data Presentations).

This post is expected to be full time on initially 6 months contract with possibility of further extension.