QA Compliance Inspector

JOB REQUIREMENTS: Minimum tertiary qualification: Bachelor’s degree in pharmacy, Chemistry, Microbiology, Biochemistry, Chemical Engineering, or a related field (NQF Level 7 or 8). Proven cGMP and QMS experience, including knowledge and application of ICH and FDA guidelines relevant to API manufacturing and/or relevant quality system certifications. Experience in batch record review, batch release processes, and quality documentation management. Proficient in Microsoft Office and related computer applications, including Word, Excel, PowerPoint, Teams, and Adobe. Exposure to Validation, Regulatory Affairs, Quality Assurance, Quality Control, and Production environments will be advantageous. OVERVIEW: Responsible for ensuring that all manufacturing activities at the facility comply with current Good Manufacturing Practices (cGMP), regulatory requirements, and internal quality standards. To provide oversight of batch documentation, batch release, audit readiness, OTIF (On-Time In-Full) support, and plant floor compliance monitoring. Collaborate with production, QC, and engineering teams to ensure GMP compliance and product quality. Promote a culture of quality and compliance across operations. ABOUT THE ROLE: Review and approve Batch Production Records (BPRs), cleaning logs, and associated documentation. Ensure completeness, accuracy, and compliance of batch records with regulatory and internal standards. Evaluate and close deviations, CAPAs, and change controls related to batch production. Make informed decisions on batch release, ensuring product quality and regulatory compliance. Compile, maintain and drive traceable and auditable batch release documentation. Collaborate with the relevant operational teams to support timely batch release. Prioritize QA activities to align with production schedules and delivery commitments. Identify and mitigate quality-related risks that could impact OTIF performance. Monitor and report on QA-related OTIF metrics and drive continuous improvement initiatives Train new staff members on SOPs in transition period (including GMP induction). Perform GMP training to support adherence to the GMP training schedule. Identify refresher or awareness training needs across the site. Prepare for and support internal audits, regulatory inspections (e.g., SAHPRA, FDA, etc.), and customer audits. Track and close audit findings and ensure timely implementation of corrective actions. Maintain audit readiness across all departments. Monitor manufacturing operations to ensure compliance with cGMP, GxP, and internal SOPs. Conduct routine inspections and compliance walkthroughs on the production floor. Provide real-time QA support during critical manufacturing and cleaning operations. Ensure plant floor activities align with quality and safety standards. Risk assessment participation, review and approval. Support IQ/OQ/PQ activities pertaining to validation. Review and approve cross contamination assessments. Perform, review and approve line clearance authorisations. Support the implementation and maintenance of the site’s Quality Management System (QMS). Participate in investigations of non-conformances and implement corrective and preventive actions. Independently assess deviations and non-conformances and make timely quality decisions. Ensure data integrity and compliance with ALCOA+ principles across all quality records. Assist in the development and revision of SOPs, work instructions, and training materials. Write, review and approve technical reports related to deviations, CAPAs, and change controls Key Competencies Strong observational skills with the ability to evaluate processes and procedures effectively Excellent organisational and administrative abilities Strong problem-solving and critical-thinking capability High attention to detail, including proofreading and auditing accuracy Ability to work independently. Ability to interpret regulations and take initiative Sound understanding and interpretation of regulations and compliance requirements Confident in addressing quality and compliance concerns across all levels of the business Strong interpersonal, effective communication, and technical writing skills Application of critical thinking to make informed and quality-driven decisions in a fast-paced environment WE ARE AN EQUAL OPPORTUNITY COMPANY AND WE APPLY EMPLOYMENT EQUITY PRINCIPLES AND STANDARDS.