QA Release Coordinator needed at Adcock Ingram

Key Job Outputs

• Plans and prioritises batch Documents co-ordination so that batches are released on due dates as per 20-08-01-001

Co-ordinates the releasing of the following:

• Adcock Ingram Critical Care (Pty) Ltd manufactured batches
• Third Party Manufacturing (Externally / Internally)
• Imported Products
• Protocol Batches
• Once all the errors have been corrected and the batch reconciles and all tests performed have passed, arranges for the Release Pharmacist to review and sign for the release of the batch.
• Performs second check that release has been entered onto the computer
• Checks that correct quantity is released on the computer against the quantity on the documents. Check expiry date is correct and that status has been changed.
• After release, signs the Release Log.
• Checks each document for correctness and any errors or omissions are followed-up.
• Contacts the personnel responsible for correcting the errors so as to ensure that no batches are released with errors or omissions.
• Enters errors on Errors List for monitoring purposes.
• Checks that there is no reconciliation discrepancy in the batch and ensures that the necessary investigatory action is taken.
• Ensures that a P21A is generated for under batches and a hold notice is raised for over batches.
• Ensure that requirements are addressed in the documentation to assure compliance.
• Correct and avoid violations of safety and GMP requirements.
• Updates existing SOPs and Specifications and/or initiates new SOPs and Specifications i.e. Ensures compliance to the following quality requirements
• Baxter
• South African Pharmacy Council
• South African Bureau of Standards
• Adcock Ingram Critical Care
• Filing of file samples and batch Documents are done timeously
• Destruction of expired file samples and batch documents as per SOP requirement
• Receiving of batch Documents and file samples from production and QC Lab

Requirements

Required Learning:

• Matric
• Understanding of SAPHRA procedures and legal requirements
• Computer literacy