Co-Ordinator: Validations
Adcock Ingram · Gauteng
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- Perform new qualification protocols OQ/PQ for HVAC, facilities, utilities, and equipment to ensure functionality and compliance with SOPs.
- Conduct re-qualification per the Validation Master Plan VMP and ensure target dates are achieved.
- Prepare, review, and execute validation protocols and reports according to cGMP standards.
- Ensure validation documentation practices are aligned with AICC and QA compliance requirements.
- Coordinate multidisciplinary project teams by facilitating sessions, conducting risk analysis, initiating change controls, and tracking progress.
- Develop and maintain in-depth technical understanding of manufacturing processes and systems.
- Proactively communicate validation progress, risks, and issues with internal and external stakeholders.
- Support regulatory audits by preparing validation documentation and responding to queries.
- Identify, plan, and implement process improvement opportunities in validation and manufacturing systems.
- Gather, analyse, and present validation data to management for decision-making.
Requirements
- Qualifications Scientific or Technical qualification in Chemistry, Chemical Engineering, Biotechnology, or related discipline essential.
- Postgraduate qualification in Quality Assurance, Validation, or Pharmaceutical Sciences – advantageous.
- Training in cGMP, GLP, and ISO/PIC/S requirements – advantageous.
Experience
- Minimum of 5 years' experience in pharmaceutical manufacturing or sterile filling essential.
- Proven on-the-job validation experience, including preparation and execution of validation protocols essential.
- Previous laboratory working experience advantageous.
- Experience in regulatory audit preparation and participation SAHPRA, ISO, PIC/S.
- Exposure to continuous improvement initiatives and lean methodologies.
Languages
- English
Other
- Ability to interpret engineering drawings and technical documentation.
- Strong computer literacy MS Office, Excel, and validation/QA systems.
- Willingness to work extended hours or shifts during critical validation activities.
- Ability to manage multidisciplinary teams and facilitate cross-functional collaboration.
- High resilience and capability to perform under pressure.