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Batch Release Pharmacist

4 weeks ago

City of Cape Town Metropolitan Municipality, South Africa Cipla Full time
Job title : Batch Release PharmacistJob Location : Western Cape, Cape TownDeadline : March 17, 2025Quick Recommended Links
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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

  • Pharmaceutical  jobs