Senior Production Pharmacist SVP at Fresenius Group

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