Quality Assurance Officer

Kedrion Biopharma; Elstree; On-site; GBP 30,000 - 40,000; Full time

Benefits offered by this job

Pension

Life insurance

On-site parking

Employee assistance programme

Virtual GP

Cycle to work scheme

Subsidised canteen

Employee discounts

Family friendly policies

Employee recognition programme

Job summary

Kedrion Biopharma seeks a Quality Assurance Officer in Elstree, focusing on maintaining high quality standards and compliance across various departments. The role involves auditing, reviewing batch records, and ensuring timely responses to quality incidents within a dynamic team environment. Ideal candidates will have a background in the pharmaceutical sector and a passion for excellence.

Qualifications

• Experience in a (bio)pharmaceutical, clean room or manufacturing environment.
• Knowledge of quality management systems, including CAPA, deviations.
• Understanding of GMP and GxP required.

Responsibilities

• Act as primary QA contact during shifts.
• Ensure compliance through audits and training.
• Process quality reports and manage quality concerns.

Skills

Quality Management Systems

Continuous Improvement

GMP

Root Cause Analysis

Deviation Reporting

Education

Relevant degree in Life Sciences or equivalent

Job description

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Join our dynamic team in Elstree, Hertfordshire, as a Quality Assurance Officer and make a significant impact across various departments, including Production, Engineering, and Technical.

In this role, you'll be at the forefront of ensuring timely resolution of quality incidents and deviations using Trackwise, while also maintaining compliance with quality systems through thorough auditing and essential training.

As the main QA point of contact during shifts, you'll play a pivotal role in promptly reviewing Batch Process Records and conducting walk rounds in different departments to uphold the highest quality standards throughout our facility. This position offers an exciting opportunity for individuals with previous experience in the pharmaceutical sector to excel and contribute to our mission of delivering excellence.

This role is on a 24/7 shift - 4 days on, 4 off, 4 nights on, 4 off - 12 hour shifts - 7am - 7pm and 7pm to 7am

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.
• To perform QA AQL sampling for Finished Products Inspection.
• Review Autoclave Batch Processing Records.
• To perform regular audits of the manufacturing facility and contribute to continuous improvement activities.
• To participate as required in Regulatory and customer audits.
• To undertake work related to job objectives as directed by QA management.

Skills & Education required to help you within the role –

• Education
• Skills and Experience
• Experience of working within a (bio) pharmaceutical, clean room or manufacturing environment.
• Experience of working within regulated Quality environment.
• Knowledge, understanding and experience of Quality Management Systems including CAPA’s, Deviations and Root Cause Analysis.
• Understanding of GMP and GxP.
• Knowledge of sterile aseptic filling and packing manufacturing processes is desirable.
• A natural tendency towards continuous improvement is required.
• Experience with blood products is desirable but not essential.
• Experience of working with documentation and quality management systems desirable.

We are seeking highly motivated and experienced individuals to drive our business forward. If you have a passion for excellence and aspire to work within a reputable pharmaceutical company, we want to hear from you.

In return we offer -

• Pension
• Life insurance
• On-site parking
• Employee assistance programme
• Virtual GP
• Cycle to work scheme
• Subsidised canteen
• Employee discounts and cash back
• Family friendly policies
• Employee recognition programme

Kedrion Biopharma is a biopharmaceutical company headquartered in Italy dedicated to collecting and fractionating blood plasma to produce and distribute plasma-derived therapies worldwide. These treatments help manage and prevent rare, ultra-rare, and debilitating conditions, including Coagulation and Neurological Disorders, Immunodeficiencies, and Rh sensitization.

The Kedrion group has numerous legacies within its brand; your employer will be Bio Products Laboratory Ltd, doing business as Kedrion Biopharma UK. Our plant is based in Elstree and counts nearly 1000 colleagues across various departments.

Since its foundation, Kedrion has experienced consistent growth, backed by strong performance indicators. Today, the company employs 5,200 people globally who work collaboratively on our portfolio of 38 life-enhancing plasma-derived products distributed in over 100 countries.

Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.

Please apply today for immediate consideration.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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