Production Pharmacist
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.
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
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
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
Skills & Knowledge
Educational qualifications:
Bachelor of Pharmacy (BPharm)
Relevant experience:
Minimum of 2 - 3 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.