Production Pharmacist - Durban at Cipla

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 behaviour by 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

Educational qualifications:

• Bachelor of Pharmacy (BPharm)

Relevant experience:

• Minimum of 3 - 5 years of experience in Pharmaceutical manufacturing plant
• Previous staff management is advantageous
• Must be a strong leader with the ability to organize, motivate the staff, and take quick and appropriate action in case of problems.