Batch Release Officer

2 months ago

Elstree, United Kingdom Bio Products Laboratory Limited Full time

Bio Products Laboratory (BPL), part of Kedrion Biopharma, is looking for a Batch Release Officer to join the Quality Department in Elstree, Hertfordshire.

The Batch Release Officer will play a crucial role as the primary QA contact for batch release and document reviews. 

Responsibilities include reviewing manufacturing batch records, ensuring completeness, collation, and readiness for QP disposition, and assisting in organising and prioritising the batch release process. 

Join us in maintaining high-quality standards and ensuring efficient batch release procedures.

Hours - 7am-3pm one week and then 11am-7pm the following week

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

Duties & Responsibilities –

  • To be primary QA contact for batch release and document review.
  • Participate in daily updates for batch release priority.
  • Review and understand deviations and changes related to batch review and be able to assess them on behalf of the QP.
  • Complete GMP reviews of batch documents.
  • Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed.
  • Complete batch review monitoring as required with any local spreadsheets or logs.
  • Complete transactions or updates in systems that support batch review such as LIMS, IFS and TrackWise.
  • To participate as required in Regulatory and customer audits.
  • To undertake work related to job objectives as directed by QA management.
  • Raising Events for errors and non-conformances in batch documentation
  • Conducting live reviews in the processing areas
  • Gain an understanding and knowledge of the process flow applicable to batch documentation reviewed (when required liaise with SME)
  • Prepare and generate Certificates of Analysis for sale of intermediates.
  • Provide intermediate assessment and release for further processing.

Experience & qualifications to make you successful in the role -

  • Degree level qualification in a Science discipline 
  • Experience of working within a (bio) pharmaceutical, clean room or manufacturing environment.
  • Knowledge of sterile aseptic filling and packing manufacturing processes is desirable.
  • The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise.
  • Experience of working with documentation and quality management systems desirable.
  • A natural tendency towards continuous improvement is required.
  • Experience with blood products is desirable but not essential.

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
  • Employee assistance programme
  • My Healthy Advantage phone app
  • Virtual GP
  • Cycle to work scheme
  • Subsided canteen

BPL is set in a secure campus surrounded by natural beauty, greenery, lakes and wildlife.

To be part of our brilliant team, please apply today.

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