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. L eads /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.