Senior Production Pharmacist SVP at Fresenius Medical Care

Description

Fresenius Kabi is a global healthcare company more than 40,500 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 purpose of this role is to ensure total compliance of the department to pharmaceutical GMP standards and support production activities from a pharmaceutical perspective.

• Responsible for the assessment of production processes in order to establish level of compliance versus pharmaceutical standards. 
• Promotion of GMP Compliance within the department. 
• Conduct product anomaly investigations and complete CAPA actions report to prevent re-occurrence of anomaly incident. Ensuring timeous close-out of events/deviations, CAPAs and change controls. 
• Responsible for the recipe creation, implementation and recipe maintenance. 
• Performs departmental internal audits to establish level of compliance and necessary corrective actions to close gaps identified. Conducts daily walk abouts to drive and enforce compliance. 
• Participates in external departmental audits and the completion of the subsequent audit finding report. 
• Conduct ad hoc product studies or trials as part of process improvement initiatives. 
• Participates in writing, reviewing and updating departmental Standard Operating Procedures. 
• Coordinate/Conduct training initiatives within the department to ensure that all staff is properly trained and competent to perform their job function. 
• Responsible for the identification of process improvement opportunities in order to prevent product loss and unnecessary product discard. 
• To take on mentoring role for pharmaceutical staff. 
• Responsible to perform investigations in the area of responsibility, with 
• Occasionally perform duties of Production Pharmacist as follows: 
• Ensures that his/her supervisors/team leaders are conversant with daily production program and organizes the department’s activities accordingly. 
• Identifies and addresses daily production problems 
• Reports / liaises daily with the Department Manager on the production situation. 
• Performs department pharmaceutical duties. 
• Is responsible for department productivity and loss control (labour, money, machines) 
• Ensures that the daily production program and targets are met. 
• Carries out ‘second line’ management function for staff problems/disputes. 
• Responsible for the department compliance with factory rules and regulations. 
• Responsible for the accurate completion and reconciliation of departmental batch book documents 
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent 
• Responsible to conduct investigations and root cause analysis through Kabitrack 

Requirements

• B Pharm Tertiary qualification.   
• Registered Pharmacist with South African Pharmacy Council 
• A minimum of 3 years pharmaceutical manufacturing experience is essential as a Senior Production Pharmacist. 
• Specific Small Volume Parenteral process technical knowledge/skills are advantageous. 
• Proven ‘hands – on’ managerial ability 
• Production management skills 
• Human resources / industrial relations skills 
• N.O.S.A awareness 
• Project Management Skills