Production Pharmacist

Production Pharmacist
 
Our client based in Durban Mobeni are looking for a Production Pharmacist to join their dynamic team.
 
Duties and Responsibilities:
 
    1. Effective utilization of resources to keep processes cost effective
    2. Participates in developing team goals and objectives, by planning resources, equipment and manpower
    3. Conducts shift handover
    4. Production plan is updated as required, in accordance with Production Planning
    5. 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 and Multitask
      • Prepare for daily operations to meet daily production outputs
5. Motivate and suggest equipment and process requirements/improvements
6. Ensures areas and equipment are clean and ready for use as per SOP
7. Ensures documentation/materials are checked as per SOP
8. Ensures Sign Off on process: such as Declaration of ready and clean for production and Authorization of Production Documents
9. Initiate operational action to prioritize shift problems and any deviations that may occur
10. Reporting any deviations and the generation of non conformance reports and investigations
11. Reporting breakdowns to maintenance
12. Monitors downtimes and problem solves with corrective action
13. Evaluates Product yields and reports deviations to Production Manager
14. Ensures product yield compiles to limits, if not initiates an investigation, collates report and discusses with Production Manager
15. Performs calculations such as yields and potency calculations
16. Assists in re-design of manufacturing methods
17. Performs training of operators on SOP’s, safety etc
18. Initiates changes once approval has been obtained
19. Accountable for product integrity
20. Writing up of SOPs
21. Generation and close out of Deviations and Change controls.
22. Conduct regular audits
23. Review and improve current documents (BMR/BPR’s, SOP’s, Log Books etc)
24. Drawing up of new BMR/BPR’s
25. Plan/organize/conduct Qualifications of equipment
26. Assist with New Product Development and validations
27. Training of staff
28. Maintenance of training matrix
29. Conduct Root Cause analysis and process optimization projects
30. 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
31. Responsible for the timeous completion of Non-conformance reports and the initiation and implementation of relevant corrective actions
32. Responsible for the timeous completion of Change Control Requests and the initiation and implementation of relevant actions
33. BMR’s and BPR’s are reviewed and made current where necessary
34. Orders and controls non-production spend items
35. Participates and supports the implementation of Best Practices and other continuous improvement initiatives
36. Ensures corrective action is taken to minimize deviations and yield transgressions
37. Prepares, reports and submits Deviations and transgression reports to QA
38. Ensures that GMP and SOP procedures are strictly adhered to
39. 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
 
Health and Safety
 
    • 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 behaviour by staff
 
Staff
 
    • Staff performance is monitored against standards and regular feedback is provided
    • Individual goals are developed and aligned to team goals and roles are clearly defined as per role profile
    • Performance discussions are held regularly to identify learning requirements
    • Training of intern pharmacists and pharmacist manufacturing assistants
 
Requirements
 
    • Matric  
    • BPharm for Pharmacist qualification
    • At least 5 years relevant experience