Production Pharmacist at Ascendis Health

JOB OBJECTIVE:

• To ensure Good Manufacturing Practice is complied with throughout the factory.
• To seek ways and methods to improve productivity in the Process streams under your control.
• To manage the activities of the Team Leaders and Line Leaders (Pharmacist Assistants) and to open production lines where necessary.
• Ensure that all Dispensary Orders are checked and signed for on the issue of materials to the process streams.
• Checking and signing of Bulk Manufacturing Tickets of registered products in area of control and authority
• Checking on weighing of raw materials for all registered products in the B1 Store area before manufacture.

JOB DESCRIPTION

• Checking that the areas and equipment are clean and that only components and products related to a specific batch are being manufactured and / or packed.
• To ensure that daily production plan is achieved in all areas.
• To ensure that machines are operated and cleaned according to company procedures and regulations.
• To ensure the machines are in good operating condition and to notify the Maintenance department where a machine is problematic.
• To liaise with B2 Store to ensure that the raw materials are received into production prior to the closing of the line running the previous batch.
• To check all registered product batch-related documentation before manufacturing, granulation, compression and final product. Also full reconciliation of yielded product and waste, and to ensure that the full quantity of waste is handed over to the QA representative for destruction according to the regulations.
• To sign the Finished Product Approval Worksheet Packing Ticket according to procedure L8, and the Master Batch Certification P27 on behalf of the Registered pharmacist for all registered products prior to release by QC.
• Ensure that the quality of products produced complies with Procedure L8 of the Company’s Protocols and standards.
• Report equipment malfunctions to the Maintenance department according to company procedures.
• Monitor the daily output on each machine.
• To reduce reject bulk and packed waste to within the loss allowance and to minimise wastage in any form throughout the company.
• Ensure optimum yields are achieved and maintained and to comment on these facts during reconciliation of the document. Investigations into process improvements must be generated from high wastage areas.
• Report on GMP Compliance and / or Non-Compliance in all areas under supervision.
• Signing-off manufacturing instructions or additions to current batches.
• Reporting any non-conformances to the Production Manager and QA Manager.
• To reduce reject bulk and packed waste to within the loss allowance and to minimize wastage in any form throughout the company.
• Ensure optimum yields are achieved and maintained and to comment on these facts during reconciliation of the document. Investigations into process improvements must be generated from high wastage areas.
• Report on GMP Compliance and / or Non-Compliance in all areas under supervision.
• Signing-off manufacturing instructions or additions to current batches.
• Initiate reworks/process adjustment and obtain the necessary authorization from the Production Manager and QA Manager to do so.
• To assist the Production Manager in the approval of Master Manufacturing Formulae, Methods, Packaging, etc.
• To communicate with customers via Planning, Orders, Marketing and Sales.
• Staff control, Discipline, Industrial Relations and Leave approval.
• Staff training on all GMP and Company SOP’s (Standard Operating Procedures).
• To report on planned versus actual output within the production department.
• To assist with stocktaking where necessary.
• To assist with validation of product processes, cleaning procedures and new equipment.
• To post all Syspro operation steps according to the documents promptly and timeously.
• To assist in ensuring good safety practices are adhered to and report any shortcomings to the Production Manager.

REQUIREMENTS

• Matric
• B.Pharm degree
• CGMP
• At least 6 months manufacturing experience