Current Vacancies at Fresenius Group

General Duties:

•  Development of User Requirement Specifications
• Development of Manufacturing Procedures
• Qualification and re-qualification of equipment and utilities
• Development and execution of System Impact Assessments and Component Impact Assessments
• Development and execution of Validation Risk Assessments and Design Reviews
• Development and execution of Design Qualifications, Installation Qualifications, Operational Qualifications and Performance Qualifications taking a System Lifecycle Approach
• Development and execution of Process Validation studies
• Validation of computerised systems validation
• Validation of Automated System
• Validation of sterilisation equipment and cycles
• Performance of Factory Acceptance Testing
• Control of delegated Validation Plans
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Requirements

• A Life Science or Chemical Engineering degree or equivalent
• 3-5 years of validation experience within the pharmaceutical manufacturing industry
• Knowledge of production processes
• Systems, product, industry and equipment knowledge
• Use of statistical techniques
• Knowledge of analytical, technical and engineering methods

Competency requirements are as follows:

• Attention to detail
• Time Management
• Planning skills; Problem solving
• Organizational skills; communication Skills
• Protocol and technical report writing skills and Computer literacy

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General Duties:

Global Responsibilities/Duties (Global-ANNNEX-HR-000003252)

• Execution of Training activities according to plan
• Providing training courses to QC learners based on controlled and informational training content
• Assessing Learners understanding of the training content

Local Responsibilities/Duties:

• Subject Matter Expert for the design of pharmaceutical processes in production, QC and QA departments with specific focus on sterile manufacturing.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner
• Responsible for the ongoing training of sterile core personnel
• Responsible for ensuring that appropriate aseptic processing control SOP’s, protocol and reporting mechanism are in place process / product integrity
• Responsible for remaining current and intimately abreast of all Quality Management principles and techniques, in Quality System per ICH Q10, Qualification & Validation (Process, Cleaning Validation, Computerized Systems Validation), Quality Risk Management (ICH Q9), Root-Cause-Assessment and Data Governance in order to provide relevant SME advise.
• Provides support to ensure the operational efficiency of the QA and QC department
• Conducts regular internal training of relevant Good Manufacturing Practices (GMP) and current industry practices
• Support in the preparation of the site for audits and inspections, towards international competent authorities
• Supports the GMP-compliant management of quality deficiencies, deviations, product failures, root cause analyses, and implementation of Corrective and Preventive actions, recording and trending of data.
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack
• Meticulous attention to detail in documentation and sterile/aseptic processing tasks.
• Collaborative and able to work effectively with cross-functional teams and stake holders. 

Requirements

• Degree or National Diploma in Science, Quality, Pharmacy, Pharmaceutical Sciences
• Min. 3 years’ experience in pharmaceutical production environment in QA, QC, Validation and sterile manufacture
• Extensive experience in inspections from SAHPRA.
• Excellent knowledge of statutory requirements on the pharmaceutical industry in South Africa
• Excellent knowledge of best practices in sterile manufacturing processes and validation.

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General Duties:

Maintain, repair & optimise plant, general facilities & associated devices                 

• Upkeep of plant, equipment, spares & relevant documentation / systems
• Plan, budget and prepare the job
• Perform maintenance
• Optimise plant, process/general equipment and systems                                       

Provide specialist technical support & enhance machine, equipment, system & process capability        

• Monitor performance
• Optimise usage of resources
• Resolve & eliminate problems

Develop preventative maintenance techniques

• Perform Root Cause analysis of failures and derive and implement preventative measures to avoid  recurrence
• Participate in team development of preventative measures to avoid unexpected failures

Manage compliance to Quality Management Systems

• Ensure adherence to all initiatives aimed at minimising impact of technical interventions on product quality

Work in teams                                                          

• Communicate effectively in the workplace
• Contribute to self and team development
• Coaching to improve plant performance
• Standby and shift work responsibilities

Environment

• Apply OHS Procedures
• Maintain Workplace Safety, housekeeping and risk free standards 
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent

Requirements

• Minimum N6 with trade.
• Trades in team balanced between Millwright, Electrician, Instrumentation Mechanician, Fitter and Turner.
• Minimum three years practical experience in the Engineering maintenance field, ideally within pharmaceutical manufacturing

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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 

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• Conversant with daily production program and schedule required pharmaceutical activities accordingly. 
• Identifies and addresses daily production problems 
• Reports / liaises daily with the production pharmacist and in case of absence with the department manager on the production situation. 
• Performs department pharmaceutical duties under the direct supervision of a qualified pharmacist 
• Is responsible for department productivity and loss control (labour, money, machines) 
• Support in the training of staff. 
• Assists the production pharmacist to write, review and update department Standard Operating Procedures and Good Manufacturing Practices. 
• Support production department that the daily production program and targets are met. 
• Capable of carrying out ‘second line’ management function for staff problems/disputes. 
• Responsible for the department compliance with factory rules and regulations. 
• Responsible for the maintenance of Good Manufacturing Practices Standards within the department. 
• Responsible for the accurate completion and reconciliation of departmental batch book documents. 
• Performs production compounding with mixing operator in line with batch record. 
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent. 

Requirements

• Understand aseptic pharmaceutical manufacturing 
• Understand quality investigation requirements (risk assessments, deviations, change controls. ie Kabitrack) 
• Batch book documentation requirements 
• Understand SOP structure 
• Understand production planning process 
• Cleanroom gowning competence 
• Understand full manufacturing process 
• Accuracy/ Attention to detail 
• Planning 
• Prioritising 
• SOP’s according to Skills Matrix