Bio Products Laboratory’s (BPL) is recruiting for a QA Batch Release Officer to join the Quality Department located in Elstree, Hertfordshire.
The Batch Release Officer will be primary QA contact for batch release and document reviews; this will include reviewing manufacturing batch records in preparation for QP disposition, ensuring batch records are complete, collated and ready for QP disposition and participate in organizing and prioritising the batch release process.
This exciting opportunity will offer the successful candidate the chance to join a company as it grows, solidifying its presence as #5 leader of Plasma Derived Medicinal Products (PDMPs) for patients and customers worldwide.
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 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.
In return we offer -
- Competitive salary, and benefits to include a company performance related bonus
- Pension
- Life Insurance
- 25 days holiday
- On-site parking and a subsidised restaurant
Headquartered in Elstree, Herts, BPL are an organisation where our products change people’s lives, and the purpose of our work is lived and breathed through its people.
Since privatising from the NHS in 2013, BPL has gone through huge change and growth as we aspire to be the leader in our field.
Bio Products Laboratory manufactures pharmaceutical products derived from human blood plasma. These products are used to treat patients for conditions such as immunodeficiencies, coagulation disorders and critical care (blood volume deficiency).
Please apply today for immediate consideration.