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Quality Assurance Officer (24/7 shift)

Bio Products Laboratory (BPL) are recruiting a Quality Assurance Officer (24/7) to assist all departments across site (primarily Production and Engineering) in prompt handling of quality incidents, deviations, customer complaints using Trackwise.

Whilst carrying out your “shop floor” walk arounds, you will ensure quality is maintained across the facility and assist in prompt review of Batch Process Records.

Headquartered in Hertfordshire, Bio Products Laboratory (BPL) invest in the latest research, technology and manufacturing methods and are continuously supplying high quality plasma-derived products worldwide.

Hours: Monday to Sunday, 7am to 7pm and 7pm to 7am

Key duties & responsibilities –

  • To be primary QA contact across site throughout shift. Being able to discern what is potentially a major or critical deviation.
  • Receive, review and process quality reports on Trackwise (eg DR/QI/CAPA records) according to define procedures.
  • Request, discuss and agree actions in response to a range of quality records including deviations, complaints and control changes as required.
  • Ensure that any documents presented for QA approval/checking are complete
  • Ensure a standard approach to quality systems throughout the facility, by undertaking both internal quality audits and QA inspections of facilities and activities, for departments across site.
  • Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff, including QA Management.
  • To co-ordinate and maintain the files for a range of quality records as required.
  • Review Batch Process Records, media fill records, autoclave records.
  • To participate as required in Regulatory and customer audits.
  • To undertake work related to job objectives as directed by QA management

Skills to help you within the role –

The following skills and experience are essential –

  • Experience working in a quality role within the pharmaceutical industry
  • Accuracy and attention to detail
  • Excellent organisational skills and time management skills
  • Excellent communication skills
  • Strong team-work skills
  • Keen eye for detail
  • Working knowledge of GMP and GXP
  • Experience working with computer systems, MS office
  • Experience using root cause analysis tools and error risk reduction tools
  • Ability to work 24/7 shift working pattern
  • The following skills and experience are desirable –
  • Working knowledge of UK/EU and US regulatory requirements
  • Working knowledge and experience with a Quality Management system, such as deviations, investigations, CAPA, customer complaints, GDP incidents.

Education (essential) –

  • Degree level qualification in science discipline or equivalent.

In return we offer –

We’re looking for highly motivated and experienced people to drive the business forward. In return you’ll be supported in developing your skills with ongoing training and career opportunities.

  • Competitive salary
  • Bonus
  • 25 days holiday
  • Pension
  • Life insurance
  • On-site parking
  • Subsided canteen

We are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people. Since privatising from the NHS in 2013, BPL has gone through huge change and growth as we aspire to be the leader in our field.

BPL is based in Borehamwood, in a secure campus surrounded by natural beauty, greenery, lakes and wildlife.

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