Job Purpose


To provide cross-functional support, ensuring stock security (out of stock, stock to norm, new launches)
To liaise with commercial and supply chain teams
To request and review batch documentation and samples for product release to market.
To approve batch reviews and release stock to market.
To conduct self-inspections and provide support during Internal audits and CAPA closure
To provide support to QMS in deviations and CR in supporting data
To maintain the Batch release training module and to utilize this module to train colleagues identified to perform batch review.
To generate Risk release reports, daily Lot release status reports, and monthly Q+R reports
To review release reports for continued relevance and either update or close off the reports upon receipt of SAHPRA post registration amendment approvals.
To compile the data required for the submission of PIT exemption applications.
To provide support for the downloading of data loggers, training and datalogger manual compilation
To provide support to the Batch release manager with respect to the compilation and maintenance of applicable departmental SOP’s.
To provide support to the Batch release manager with respect to the monthly Q and R report.


Accountabilities


Perform Batch Reviews
Perform Batch Release/Approvals
Lot release of Vaccines
Lot release of other Biologicals
Maintenance and utilization of the Batch release training module for new reviewers
Generation, review and update of release reports
Type 1A variations
Collation of data required for the application of exemption of PIT
Provides Batch Release support with downloading of data loggers.
Develops and maintains SOP’s.
Provides support to the Batch Release Manager
Training 
Managing direct report/s
Pharmacovigilance
Any other reasonable duties


Education Qualification


B.Pharm


Relevant Work Experience


Pharmaceutical industry experience would be essential
Quality assurance knowledge would be essential
Experience in Lot Release would be beneficial
Experience in Regulatory would be beneficial
Experience in Supply chain would be beneficial