Batch Release Pharmacist at Cipla

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