Fresenius Kabi Manufacturing SA (Pty) Ltd: Validation Officer

Company Fresenius Kabi Manufacturing SA (Pty) Ltd
Reference # SV-QAVO
Published 26/10/2020
Contract Type Permanent
Salary Market Related
Location Port Elizabeth, Eastern Cape, South Africa
Fresenius Kabi is a global healthcare company with over 39 000 employees worldwide.
We offer employees of diverse cultures and backgrounds a wide range of fulfilling and challenging career and personal growth opportunities both domestically and internationally.
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 ideal candidate for this vacancy will be a graduate with extensive validation experience within the aseptic pharmaceutical manufacturing industry.

The successful candidate will be responsible for preparing, planning, co-ordinating and executing all site validation activities.
Furthermore, they will be responsible for ensuring that the validation department complies with SAHPRA/cGMP/PICS and corporate guidelines.

Job Functions Investigation & Compliance,Mathematics, Statistics and Information,Monitoring & Evaluation,Operations,Statistics
Industries Manufacturing,Pharmaceutical / Medical / Healthcare / Hygiene
The key responsibilities and duties are as follows:

•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 and Site Acceptance Testing
•Control of delegated Validation Plans

The minimum qualification is a Life Science or Engineering degree or equivalent

The minimum knowledge, skills and experience are as follows:
•3-5 years of validation experience within the pharmaceutical industry
•Knowledge of production processes
•Systems, product, industry and equipment knowledge
•Use of statistical techniques
•Knowledge of analytical, technical and engineering methods
•Attention to detail
•Time Management
•Planning skills; Problem solving
•Organizational skills; communication Skills
•Protocol and technical report writing skills and Computer literacy

Job Closing Date 09/11/2020