Job Summary
Do you have a keen eye for detail and a passion for maintaining high standards?
Kedrion Biopharma is looking for a meticulous Quality Assurance Batch Release Officer to join our dynamic team at our Elstree, Hertfordshire site. This role is ideal for individuals with a strong commitment to quality and accuracy. Experience in pharmaceutical manufacturing is a plus, but we also welcome candidates with transferable skills from other industries.
In this role, you will be responsible for reviewing manufacturing batch records in preparation for Qualified Person (QP) disposition. You will ensure that batch records are complete, collated, and ready for QP disposition, working closely with the manufacturing team to correct any batch record errors and review deviations related to batch release. Your expertise will be crucial in collating reviewed batch records and supporting QP’s in making batch disposition decisions. Additionally, you will play an integral part in organizing and prioritizing the batch release process, ensuring efficiency and compliance at every step.
Join us at Kedrion Biopharma and contribute to our mission of delivering high-quality biopharmaceutical products that improve the lives of patients worldwide.
Hours - Monday to Friday. 7am-3pm one week, then 11am-7pm the next week and alternating thereafter
Our site is not easily accessible by public transport so please take this into consideration when applying as this role is fully on-site.
What you'll do
- 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.
Qualifications and need-to-know
- Degree level qualification in science discipline or equivalent.
- 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.
Please apply today for immediate consideration!
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
- Annual bonus scheme
- 25 days holiday (plus bank holidays)
- Pension
- Life insurance
- On-site parking
- Employee assistance programme
- Virtual GP
- Cycle to work scheme
- Subsidised canteen
- Employee discounts and cash back
- Gym membership discounts
- Family friendly policies
- Employee recognition programme
- Loyal service awards
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.
Please apply today for immediate consideration!