Quality Assurance Officer

  • Location

    Hertfordshire, England

  • Sector:

    Healthcare

  • Job type:

    Permanent

  • Salary:

    £25000 - £30000 per annum

  • Contact:

    Experis UK

  • Contact email:

    Paul.White@experis.co.uk

  • Job ref:

    PW/399_1604505563

  • Published:

    2 months ago

  • Expiry date:

    2020-11-17

  • Start date:

    ASAP

  • Client:

    #

Quality Assurance Officer (QA)

Permanent opportunity

Hertfordshire

Salary: £25,000 - £30,000 base + bens

ASAP Start

OVERVIEW:

Our client is a specialist pharmaceutical company right at the heart of the UK Pharmaceutical distribution network. Due to consistent investment and innovative management they are seeking a Quality Assurance Officer to come on board at the Hertfordshire site.

CURRENT RESPONSIBILITIES:

  • Quality document review prior to QP release.
  • Generating BPRs for manufacturing.
  • Amending Manufacturing and Packaging master production records.
  • Reviewing & approving BOMs on SAGE.
  • Preparing batch release documentation, C of A and Batch Release Certificate.
  • Handling customer complaints and enquiries, including medical product information, coordinate technical product complaint investigations.
  • Handling and reporting of Adverse Drug Reactions / Adverse Events. Liaising with HPPV (third party Pharmacovigilance).
  • Product Quality Report preparation.
  • Raising and assessing deviations, change controls & CAPAs.
  • Artwork management including liaising with regulatory affairs and third party.
  • Controlled document management (versioning & database management).
  • Authoring and reviewing controlled documents (manufacturing logs, SOPs, etc.).
  • Raising purchase orders for artwork tasks and packaging materials.
  • Internal, external and customer audits.(Co-Auditor)
  • Laboratory systems administration.
  • General IT & administration assistance for all departments.
  • Generating investigation reports.
  • New QA staff training.

SKILLS/EXPERIENCE NEEDED:

  • Life Science degree or relevant equivalent industry experience.
  • 2+ years' experience in Pharmaceuticals and good understanding of industry standards.
  • Experienced working with a QMS and uploading data from start to finish.
  • Experience with GMP, NCR's and CAPA.
  • Hands-on experience in PQR
  • Batch document review
  • Change control management
  • Deviation handling
  • Artwork skills
  • Self-inspection
  • CAPA management skills
  • KPI's generation

Due to the high volume of applications we receive we are not able to get back to everyone who applies. Therefore if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.