Co-Ordinator: Validations at Adcock Ingram

MAIN TASKS / RESPONSIBILITIES:

• 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.