QA Validation Officer at Adcock Ingram

Job Purpose

• To coordinate, execute, review and continuously improve validation, qualification activities in the analytical laboratory, ensuring compliance with current regulatory requirements (SAHPRA, PIC/S, WHO, EMA), while identifying risks and improvement opportunities. Additionally, the candidate is required to perform site QA support activities including Post Importation analysis approval and management, and general QA documentation control and issuance.
• The ideal candidate should have hands-on experience in pharmaceutical quality control analysis and review, Validation/ qualification, with sufficient knowledge to independently manage and execute assigned responsibilities.

Key Job Outputs

Validation & Qualification Activities

• Prepare, review and maintain equipment validation documentation (User Requirement Specifications (URS), Validation Protocols, Reports and Appendices, etc)
• Perform risk assessments related to validations, deviations and OOS
• Review and approve Qualification documentation for equipment, systems and processes.
• Track validation/qualification timelines and deliverables
• Maintain the asset register, calibration/ verification/ PPM/ requalification schedules linked to validation and qualification, for monthly reports
• Support qualification and validation activities for computerized systems in the analytical lab.
• Support data integrity initiatives and compliance with ALCOA+ principles
• Co-ordination of internal and external equipment, utilities, facility calibration/ verification schedules, including follow-up and coordination of approval

Quality Management System (QMS)

• Support the implementation, maintenance, and continual improvement of the QMS.
• Review and update of the Validation Master Plan (manual), Site Master File (SMF), Quality Manual and Laboratory information file (LIF)
• Compile, review, update and issue SOPs and Work Instructions (WI)
• Update of annual training schedules and job specific training schedules (QA and laboratory)
• Ensure Deviations and OOS events are logged, support investigations to closure
• Ensure Change Controls are initiated, reviewed and progressed to approval and implementation
• Perform internal audits and support regulatory inspections
• Weekly update of QMS monitoring
• Issuance and filing of documentation
• Archive Store management
• Perform additional QA-related tasks and responsibilities as required to support business needs

Laboratory Support

• Coordinate post-importation activities, including sample registration and tracking, allocation, approval of results, Certificate of Analysis (CoA) compilation, retention sample management, and document archiving

Accountabilities

• Support compliance of validation and qualification activities for equipment, utilities, and facilities with regulatory requirements.
• Maintain accuracy, completeness, and timeliness of all quality and validation documentation.
• Ensure compliance with post-importation processes to achieve right-first-time outcomes.
• Contribute to continual improvement of validation and quality processes.
• Support audit readiness and contribute to successful regulatory inspections.

Core Competencies

 Technical & Digital Competencies

• Intermediate to Advanced Computer Skills including Microsoft Excel (advanced formulas, data analysis, validation), Microsoft Word and Microsoft PowerPoint (professional presentations and training material).
• Strong understanding of computer systems validation and data integrity principles.
• Practical application of AI tools for data analysis, trend evaluation, and workflow efficiency improvements, would be an advantage.

 Behavioural Competencies

• Strong analytical and problem-solving skills
• Excellent technical writing and communication skills.
• Ability to work independently and collaboratively across departments.
• Strong organisational and time-management skills.
• High attention to detail with a quality-focused mindset.

Requirements

• National Diploma / BSc in Chemistry or related BSc, Chemical Engineering, Pharmaceutical Sciences, or related scientific discipline.
• A minimum of 3-5 years experience in the pharmaceutical industry.
• Demonstrable experience in Validation and Qualification activities, Quality Management Systems and Quality Control activities.