Batch Release Pharmacist

Division

Quality

Department

Quality Assurance

Employment Type

Permanent

Job Purpose

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

Employment Equity

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