Jobs at Fresenius Kabi

GENERAL DUTIES:

• Subject Matter Expert for the Technology Transfer processes in production, QC and QA departments with specific focus on regulatory, sterile manufacturing and validation.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner
• To develop and maintain cooperative relationships with all regulatory bodies as well as in the maintenance of registration documents/applications/databases of all products in applicable countries.
• Ensure that local regulatory affairs unit applies latest procedures and guidelines as published.
• Contribute to the compilation of registration dossiers for submissions to authorities and relevant bodies.
• Subject Matter Expert for regulatory, validation, GMP requirements, QA and QC processes.
• Responsible for ensuring that appropriate SOP’s, protocol and reporting mechanism are in place for Regulatory portfolio, Technology Transfer and related processes
• Responsible for being the single point of contact for Technology Transfer with the sales entity.
• Participating in review of any incidents / environmental excursions / anomalous events with potential for impact on process / product integrity / technology transfer.
• General Duties
• Subject Matter Expert for the Technology Transfer processes in production, QC and QA departments with specific focus on regulatory, sterile manufacturing and validation.
• Responsible for leveraging and transferring own knowledge and expertise to the local teams in a systematic, structured, documented and auditable manner
• To develop and maintain cooperative relationships with all regulatory bodies as well as in the maintenance of registration documents/applications/databases of all products in applicable countries.
• Ensure that local regulatory affairs unit applies latest procedures and guidelines as published.
• Contribute to the compilation of registration dossiers for submissions to authorities and relevant bodies.
• Subject Matter Expert for regulatory, validation, GMP requirements, QA and QC processes.
• Responsible for ensuring that appropriate SOP’s, protocol and reporting mechanism are in place for Regulatory portfolio, Technology Transfer and related processes
• Responsible for being the single point of contact for Technology Transfer with the sales entity.
• Participating in review of any incidents / environmental excursions / anomalous events with potential for impact on process / product integrity / technology transfer.
• Responsible for advising and being actively involved with investment decisions at PU Port Elizabeth.
• 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.
• Management System, e.g. Deviation Management, CAPAs, Document Control, Quality Risk Management, Root Cause Analysis and Change Control
• Support in Product Quality Review process
• Responsible to perform investigations in the area of responsibility, with the support of the tool Kabitrack

Requirements

• Degree or National Diploma in Science, Quality, Pharmacy, Pharmaceutical Sciences
• 5-10 years’ experience in Pharmaceutical production environment in QA, QC, Validation and sterile manufacture
• Extensive experience in inspections from SAHPRA
• Excellent knowledge of regulatory affairs, statutory requirements on the pharmaceutical industry in South Africa
• Excellent knowledge of best practices in technology transfer
• Extensive problem solving and product research and development knowledge

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Duties:

• 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
• From time to time carry out other jobs within the department / factory, which are consistent with the grade, qualification and training of the incumbent.
• Understand quality investigation requirements (risk assessments, deviations, change controls. i.e., Kabitrack)
• Batch book documentation requirements
• Understand SOP structure
• Understand production planning process
• Cleanroom gowning competence
• Understand full manufacturing process
• Accuracy/ Attention to detail
• Planning
• Prioritizing
• SOP’s according to Skills Matrix

Requirements

• Registered as Technician with the South African Pharmacy Council plus a 6-months internship
• Pharmaceutical manufacturing experience.
• Human resources / industrial relations skills
• N.O.S.A awareness
• Visual Packaging in LVP or SVP
• 3 months process experience

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Duties:

• Responsible for co-ordinating and allocating work to the staff in the chemistry laboratory
• Co-ordinate all chemical testing of raw materials, components, water, LVP, SVP, and intermediates in conjunction with the supervisors
• Co-ordinate the on-going stability testing programme, liaison with the responsible analyst, microbiology manager and the pharmaceutical services manager
• Involved in new product development and co-ordinate testing as required
• Responsible for scheduling HPLC method validations, product and method evaluations, production and customer queries
• Checking and approval of new specifications, updates to existing specifications and validations
• The evaluation of new raw material suppliers and submission of reports to the pharmaceutical services manager
• Ensure that all laboratory equipment is maintained and calibrated regularly following the relevant standard operating procedure
• Ensure routine maintenance is performed of laboratory equipment where possible
• Responsible for the pricing, ordering and receipt of all chemicals, standards, glassware, equipment and consumables for the laboratory
• Ensure that the chemistry laboratory stays abreast with new technology and development
• Ensure Good Laboratory Practice and safety principles are applied to and adhered to at all times
• Ensure Good Manufacturing Practices and ISO01025 and ISO9001 are implemented and adhered to by all Chemistry Lab employees
• Involved in trouble shooting in the lab and assist where possible in the factory
• Writing, review and approval of standard operating procedures
• Maintain a suitable control system, ensuring analysis, document, standard and equipment traceability
• Conduct ISO 9002 internal factory audits
• 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. 

Budget and Cost Control

• Control and optimise the cost within the department
• Set quality and performance KPI’s for the department and monitor the departmental performance on a defined frequency
• Continuously improve processes to introduce World Class Manufacturing practices within the business
• Identify opportunities for productivity and efficiency improvements

Human Resources Management

• Manage all personnel in the department including disciplinary procedures
• Ensure that all personnel in the department is developed and trained as required by the various job functions
• Recruitment of staff
• Staff development regarding identifying needs and opportunities
• Performance Management evaluation
• Review salaries and promotions if applicable
• Implementation of equity plan as set out in the Employment Equity Policy
• Responsible to conduct investigations and root cause analysis through Kabitrack

Requirements

• BSc or NTD or HNTD Analytical Chemistry
• 5 years’ experience within pharmaceutical manufacturing
• 2 years managerial or supervisory experience
• Aseptic Manufacturing knowledge
• GMP Principals
• GLP and safety principles
• Understand SOP system
• Understanding of the Quality Management system ISO9001
• Understand quality investigation requirements (risk assessments, deviations, change controls ie. Kabitrack)
• Understanding waste and disposal of samples (schedule 5 and 6 stability samples)
• Experience in Audit
• Detailed knowledge of requirements for chemical testing of raw materials, components, water, LVP, and SVP
• Understand stability testing programme
• Skills in correct use of laboratory equipment
• Understand technical transfer of product