Quality Assurance Officer

at  Bpl

Bio Products Laboratory (BPL), part of the Kedrion Group, 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.
This exciting opportunity will offer the successful candidate the unique opportunity to help build a modern, positive, and strong image for the company as it grows, solidifying its presence as rank #5 leader of Plasma Derived Medicinal Products (PDMPs) for patients and customers worldwide.
Hours: Monday to Sunday, 7am to 7pm and 7pm to 7am (4 days on, 4 off, 4 nights on, 4 off)
Location: Elstree, Hertfordshire

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
• Subsidised canteen

BPL is based in Elstree, Hertfordshire, in a secure campus surrounded by natural beauty, greenery, lakes and wildlife.
Please apply today for further information.

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