Production Pharmacist

8 months ago

Durban, South Africa Cipla Full time

Job Title

Production Pharmacist

Location

Durban, Mobeni

**Job Purpose**

Coordinates and controls production activities under the supervision of the Manufacturing Manager and Head of Production. Implements the production plan and targets according to cGMP, while maintaining the highest level of Quality, Safety and Productivity. Upholds and maintains all legislative requirements when reviewing and approving all production and related activities, within the scope of a legally appointed Pharmacist. Leads /supervisors employees engaged in production activities. This role depending on production needs will allow for rotation withing the manufacturing/packaging and warehouse departments.

**Key Accountabilities**
- Effective utilization of resources to keep processes cost effective
- Participates in developing team goals and objectives, by planning resources, equipment and manpower
- Conducts shift handover
- Production plan is updated as required, in accordance with Production Planning
- Contingency plans for production are generated and implemented as and when required
- Be accountable for shift production and translating targets into outputs
- Forecast possible problem areas and non-conformances that could potentially affect production
- Reporting breakdowns and stoppages to direct line Manager/relevant responsible persons
- Timekeeping of staff
- Ensure timeous receipt of materials from stores
- Ensure timeous receipt of QA documents
- Able to co-ordinate Production activities
- Multitask
- Prepare for daily operations to meet daily production outputs
- Motivate and suggest equipment and process requirements/improvements
- Ensures areas and equipment are clean and ready for use as per SOP
- Ensures documentation/materials are checked as per SOP
- Ensures Sign Off on process:

- Declaration of ready and clean for production
- Authorization of Production Documents
- Initiate operational action to prioritize shift problems and any deviations that may occur
- Reporting any deviations and the generation of non-conformance reports and investigations
- Reporting breakdowns to maintenance
- Monitors downtimes and problem solves with corrective action
- Evaluates Product yields and reports deviations to Production Manager
- Ensures product yield compiles to limits, if not initiates an investigation, collates report and discusses with Production Manager
- Performs calculations such as yields and potency calculations
- Assists in re-design of manufacturing methods
- Performs training of operators on SOP’s, safety etc
- Initiates changes once approval has been obtained
- Accountable for product integrity
- Writing up of SOPs
- Generation and close out of Deviations and Change controls.
- Conduct regular audits
- Review and improve current documents (BMR/BPR’s, SOP’s, Log Books etc)
- Drawing up of new BMR/BPR’s
- Plan/organize/conduct Qualifications of equipment
- Assist with New Product Development and validations
- Training of staff
- Maintenance of training matrix
- Conduct Root Cause analysis and process optimization projects
- Responsible for ensuring the ‘real time’ completion of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR), Log Sheets, Syspro Transaction etc. during all production processes. (Reconcile, audit, queries resolved before QA login
- Responsible for the timeous completion of Non-conformance reports and the initiation and implementation of relevant corrective actions
- Responsible for the timeous completion of Change Control Requests and the initiation and implementation of relevant actions
- BMR’s and BPR’s are reviewed and made current where necessary
- Orders and controls non-production spend items
- Participates and supports the implementation of Best Practices and other continuous improvement initiatives
- Ensures corrective action is taken to minimize deviations and yield transgressions
- Prepares, reports and submits Deviations and transgression reports to QA
- Ensures that GMP and SOP procedures are strictly adhered to
- Monitors quality checks including in-process controls according to SOP, reviews and improves if necessary
- Responsible for Document Procedure Compliance:

- Sign-on
- Completion
- Verification as per SOP
- Audit docs before QA login and final signoff
- Safety and health problems are identified and reported to the safety rep for rectifying
- Hazardous situations resolved immediately or reported to Production Manager
- Equipment is available and ready for use
- Incidents/accidents are prevented by effective operating of equipment and machinery, and following health and safety procedures
- Health and safety procedures are adhered to
- The work area is safe and clean as per company policy
- SOPs are followed
- Performance issues are accurately identified and action instituted
- Potential conflict is resolved according to IR procedures
- Disciplinary action is taken according to the IR policy - in cases of poor performance and inappropriate

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