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Quality Assurance Officer

Kedrion Biopharma
Elstree
4 months ago
Applications closed

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Join our dynamic team in Elstree, Hertfordshire, as aQuality Assurance Officerand 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 levelEntry level

Employment type

  • Employment typeFull-time

Job function

  • Job functionQuality Assurance
  • IndustriesPharmaceutical Manufacturing

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