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Bath ASU, Sterility Assurance Lead, Corsham, Wiltshire

Bath ASU

Sterility Assurance Lead
Corsham, Wiltshire

(Permanent – 37.5 hours per week, with a requirement to be flexible)

“Do you want to work for an organisation that makes life-changing pharmaceuticals?
If yes then read on…”

We are recruiting for Sterility Assurance Lead to join our established QA team. This is an exciting new position to support our company strategy and ensure that we continue to deliver an exceptional service to the business and our customers.

About you

We are looking for a self-motivated, energetic individual with a proven track record of working as a Sterility Assurance Lead within a fast-paced environment. You should have 5 years + experience of working in a quality role such as Sterility Assurance or Microbiology. Thorough knowledge and experience of the principles of sterility assurance, quality system design, development and successful registration of GMP facilities, with excellent communication and organisation skills are essential for this role.

To undertake this role, you should have practical manufacturing experience and be able to demonstrate technical knowledge of aseptic manufacturing. You should be able to work independently or as part of a team according to the demands of the job. The successful candidate must have good PQS system knowledge (deviations, CAPAs, change control, complaints handling) and awareness of current best practice and opportunities for improvement.

We are looking for someone who is a member or eligible to be a member of Royal Society of Biology.

What will be expected of you

As Sterility Assurance Lead deliver a safe quality aseptic manufacturing service to meet cGMP requirements and the needs of the business.

The Sterility Assurance Lead is responsible for leading the trending and review of environmental monitoring data; for coordinating and producing investigation reports and assessing CAPA action items.

The role will involve liaising with departments including QA, QC, Production and Warehouse, as well as visits to the aseptic processing facilities.

Duties and Responsibilities:

  • To provide daily communication with Production Management and QA Management
  • To operate a system for trending all microbiology investigations and deviations and to report out this information on a weekly basis
  • To oversee investigations pertaining to sterility assurance and to support the closure of items.
  • To oversee CAPAs pertaining to sterility assurance and to support the closure of items.
  • To update documents and SOPs as required.
  • To input into continuous improvement initiatives.
  • To ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
  • To participate in management reviews of process performance, product quality and of the pharmaceutical quality system.
  • To be part of the on call rota

Secondary Duties

  • To undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
  • To be responsible for the Approval for Use (release) of all products manufactured or repackaged within Qualasept according to licensing requirements, GMP and professional discretion.
  • To support the training and development of Production and Quality staff.
  • To ensure that staff comply with COSHH and Health and Safety Regulations and appropriate departmental procedures.
  • To support the development of activities and policies aimed at improving the effectiveness and efficiency of the service and improvement of the quality management system.
  • To identify and implement best practice.
  • Other duties as required by the Head of Quality.


In return we offer rewards and benefits including:

  • Salary circa £40k per annum (dependent on experience, knowledge & skills)
  • 29 days paid holiday, increasing with service up to 34 days (including bank holidays)
  • Company pension scheme (enhanced company contribution)
  • Life Assurance
  • Company bonus scheme
  • Additional non-contractual benefits including free breakfast and outdoor gym

Nestled in the heart of the West Country with easy access to the World Heritage City of Bath, and with great transport links to London and private education you can experience an unparalleled quality of life in a company that also has a zero-carbon status. Commit to excellence, join our team “Where patients come first”.

About the company

The Qualasept Pharmaxo Holdings Limited (QPHL) Group operates within the pharmaceutical aseptic compounding, clinical homecare and laboratory services sectors.

Qualasept Ltd t/a Bath ASU produces over 3,000 aseptically compounded injectable pharmaceutical products each day for hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need of pain relief. Through our scientific and technology capabilities, the team continuously develops new and innovative methods to improve our products and services.

Pharmaxo Pharmacy Services Limited is a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.

Microgenetics Ltd is a microbiological services business currently in its developmental stage. Its aim is to bring to market innovative microbiological testing and monitoring services, methodologies and technologies in the pharmaceutical manufacturing and clinical/diagnostics sectors.

The QPHL Group now includes over 300 people with a leading edge turnover greater than £190 million.

We have invested in a new, multi-million pound manufacturing facility and offices in Corsham, Wiltshire – offering an unrivalled opportunity in a successful and expanding company with a great team spirit.

How to apply

If you would like a full job description for this position or would like to apply with covering letter and CV detailing what experience, knowledge and skills you could bring to this role, please email

Closing date for completed applications is 21st October 2019. If you have been successful at shortlisting you will back by 23rd October and interviews will take place w/c 28th October 2019.