Role Purpose
To ensure that the manufacturing facilities, processes, analytical methods and systems are validated in full compliance with cGMP and regulatory requirements so as to meet the stipulated product quality standards, from starting material to finished pharmaceutical product.
Required Role Qualifications
- Grade 12 or NQF Level 4.
- Diploma/Degree in Chemistry/Microbiology.
- Min 2 years’ of validation experience in a pharmaceutical manufacturing environment.
- Excellent understanding of HVAC, utilities, cleaning, analytical method, product and process qualification/validation.
Required Role Skills and Abilities
- Computer literate with an excellent grasp of MS Office Suite.
- Effective verbal and written communication.
- Strong interpersonal & negotiation skills.
- Problem-solving skills.
- Strategic planning & excellent prioritisation skills.
- Excellent document management.
- Organised with good time management.
- Must work well under pressure while maintaining attention to details.
Role Responsibilities
General
- Actively lead & be involved in the execution of all stages of validation.
- Represent the company as a validation lead on validation projects.
- Liaise with key individuals within project teams to ensure validation activities are managed and completed in a timely manner.
- Regularly update the QA Manager on the status of validation projects and escape issues when required.
- Support ongoing validation lifecycle management to provide confidence that validated systems/processes remain fit for use.
- Plan & execute transfer of technology projects.
- Undertake additional duties or specific projects as required.
Documentation
- Compile and/or review SOPs related to validations.
- Ensure all information required for development of validation documents is available.
- Generate validation documents including plans and strategies.
- Proactively manage validation planning & preparation of validation documents in advance.
Quality assurance
- Keep up to date with regulatory and industry standards governing validation and implement changes proactively.
- Review and approve change requests relating to changes to validated systems/processes.
- Support investigations into validation events and propose corrections and CAPAs as appropriate.
- Present on validation during internal audits.
Training
- Ensure training is performed and compliant to regulatory requirements during the validation lifecycle.
- Train and mentor those executing validation in the content of the validation exercise & expectations thereof.
- Train employees in new and/or updated validation SOPs.
White River
Published Date: 12 January 2026
Closing Date: 28 February 2026