Quality Assurance Officer 24/7 - Borehamwood, United Kingdom - BPL

BPL

Verified Company

Borehamwood, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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

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.

Hours**:
Monday to Sunday, 7am to 7pm and 7pm to 7am (4 days on, 4 off, 4 nights on, 4 off)

Location:
Elstree (Borehamwood), Herts

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 coordinate 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 -
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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 teamwork 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

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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.