Job Description

Division

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Quality

Department

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Quality Assurance

Employment Type

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Permanent

Job Purpose

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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

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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

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B.Pharm

Relevant Work Experience

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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

Employment Equity

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Cipla is an Employment Equity employer, and this position will be filled based on our Employment Equity Plan.