Hobson Prior are looking for a Batch Release Coordinator to join a brilliant pharmaceuticals organisation on a 1-year contract in South Africa. For more information, please get in touch now!

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• In this role, you will maintain oversight for status of individual batches, including sampling, testing, deviations, and target release timelines; communicate status accurately and succinctly.
• Review batch documentation provided by external manufacturing site for compliance with cGMPs, Janssen standards, and product specifications. Ensure all required testing and documentation is provided and meets release requirements.
• You will be responsible for performing batch disposition in accordance with Janssen Supply Chain (JSC) procedures.
• Manage/track OMCL/CBER samples from EM to final shipment to government facility.
• Generate OMCL/CBER protocols for lot release.
• Enter data into eLIMS.
• Alert Supervision of any nonconforming results, out of trend, or out of specification results.
• Support supply chain logistics for on time shipment from CMO to Warehouse.

Requirements:

• The ideal candidate will have a Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline.
• At least 4 years working in a pharmaceutical regulated environment.
• Strong experience with pharmaceutical aseptic processing operations or quality assurance.
• Detailed knowledge of cGMPs related to pharmaceutical production.
• Excellent interpersonal and written/oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited information required.
• Advanced degrees are a plus and may reduce the experience required.
• Experience in vaccines production is preferred.
• Experience in the OMCL/CBER process for vaccine government approval/release is preferred.
• Proficient in applying process excellence tools and methodologies is preferred.
• Experience working with external manufacturers is preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.