Release Pharmacist at Fresenius Group

Description

• Fresenius Kabi is a global healthcare company with over 39 000 employees worldwide.
• We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do. 
• The manufacturing plant in Port Elizabeth produces both small and large volume parenterals. 
• The main purpose of the Release Pharmacist is the Promotion and execution of control activities necessary to provide product quality compliance and assurance.  Approving or rejection of intermediates, finished products and components for use or supply to the market. 

General shared Duties:

• Approval and Release of production batches 
• Review of batch documentation: Assessment should embrace all relevant factors including production conditions, results of in-process testing, review of manufacturing, packaging and laboratory documentation and compliance with finished product specification. 
• When all required parameters are satisfied including the documentation audit, the release pharmacist may recommend release of the product from its quarantine status. 
• Approval and Release of Third-party manufacture products Printed packaging and Intermediates 
• Responsibility for ensuring that the following requirements with regards to release of finished products have been met: 
• the marketing authorization and the manufacturing authorization requirements for the product have been met for the batch concerned. 
• the principles and guidelines of GMP have been followed. 
• the principal manufacturing and testing processes have been validated. 
• all the necessary checks and tests have been performed and account taken of the production conditions and manufacturing records. 
• any planned changes or deviations in manufacturing or quality control have been approved in accordance with the QMS before any product is released. 
• any additional sampling, inspection, tests and checks have been carried out or initiated, as appropriate, to cover planned changes and deviations. 
• all necessary production and QC documentation has been completed in line with the various SOP’s. 
• all relevant factors have been considered, including any not specifically associated with the output batch directly under review. 
• Involvement in decision making of rejected goods, materials, components. 
• Monitoring and auditing compliance to both regulatory requirements and in-house standards with regards to current good manufacturing practice. 
• Participate in internal audits 
• General process evaluation.  This includes reporting of observed deficiencies to the correct persons and follow-up on corrective action, liaising with production where necessary. 
• Involvement in project decisions which may affect the quality of product. 
• Shared responsibility with production for the investigation into a solution of quality problems as well as preventative planning and action. 
• Provision of assistance to production with pharmaceutical cover when so necessary e.g., Compounding, line opening, dispensing, where there is no conflict of interest. 
• Input into factory training needs. 
• Co-ordination, checking and sign-off of Certificates of Analysis and Certificates of Conformance for third party manufactured products and exports. 
• Transfer of released stock from quarantine to the finished goods warehouse on the computer system. 
• From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent. 

Requirements

• B. Pharm / Dip. Pharm. 
• Registered Pharmacist with South African Pharmacy Council. 
• Minimum of 2 years experience as a release pharmacist
• Previous experience / background in industry / technical manufacturing / validation activities as well as possession of formal quality control qualifications would be advantageous. 
• Working knowledge of ISO QMS and GMP Regulations
• Ability to work with figures
• Attention to detail
• Must be highly self motivated