
carolyne Mabwa
Manufacturing / Mechanical
About carolyne Mabwa:
- Highly experienced QA Manager with 17+ years in manufacturing environments, including food, biotech, and industrial production.
- Expertise in GMP and Integrated Management Systems (IMS), CAPA, deviation handling, supplier qualification, regulatory compliance, and documentation control.
- Proven leadership in audit readiness, risk management, product release, and continuous improvement programs.
- Strong cross-functional collaborator with excellent problem-solving, communication, and decision-making skills.
Experience
- Lead IMS-aligned systems across production and laboratory operations.
- Oversee batch release, stability testing, traceability, and documentation approval.
- Manage CAPA, deviations, OOS investigations, and supplier quality programs.
- Conduct internal audits and prepare for regulatory inspections.
- Supervise QA staff, assign tasks, and promote a culture of quality.
- Implemented ISO 9001 and HACCP-compliant IMS.
- Managed product inspections, deviations, CAPA systems, and supplier audits.
- Approved COAs, MSDSs, and material specifications.
- Led QA team training, performance evaluation, and new product validation support.
- Oversaw IMS and GMP compliance across food and production operations.
- Managed supplier audits, ingredient compliance, traceability, and recalls.
- Supervised hygiene, sanitation, and warehouse QA systems.
- Led internal audits and employee training on QA standards.
- Managed ISO 9001, ISO 22000, GMP, and HACCP within an IMS framework.
- Oversaw batch release, allergen management, and sanitation validation.
- Controlled raw material, packaging, and finished product approvals.
- Investigated customer complaints and executed CAPA.
- Supported new product development and scale-up validation.
- Supervised laboratory operations and analytical testing.
- Controlled raw material, packaging, WIP, and finished product inspections.
- Ensured GMP compliance, hygiene audits, and documentation control.
- Investigated deviations and implemented corrective actions.
Education
Implemented and sustained a fully integrated Quality, Risk, and Compliance Management System (IMS) aligned with ISO 9001, ISO 22000, GMP, and HACCP, achieving a 100% audit certification success rate.
Led 20+ regulatory, customer, and certification audits with zero major non-conformities, strengthening corporate compliance and governance.
Established enterprise-wide risk management frameworks and risk registers, reducing critical operational and product safety risks by 60%+.
Improved batch release turnaround time by 35% while strengthening allergen control, sanitation validation, and documentation integrity.
Reduced quality incidents (deviations, OOS, non-conformities, and customer complaints) by 50%+ through advanced CAPA, root-cause analysis, and preventive risk controls.
Directed 30+ supplier quality and compliance audits, raising supplier compliance from 70% to over 95%, and strengthening traceability and recall readiness with 100% trace-back success within 2 hours.
Led 100% approval control for raw materials, packaging, WIP, and finished products, eliminating material-related production shutdowns and compliance breaches.
Built and led a cross-functional QA, Risk, and Compliance team of 10–15 staff, improving staff performance and compliance adherence by 40% via targeted training and competency programs.
Strengthened GMP, hygiene, sanitation, and warehouse compliance, improving inspection readiness scores by 45% and significantly reducing contamination and regulatory risks.
Delivered 10+ fully compliant new product launches, ensuring complete risk assessment (HACCP, FMEA), validation, and regulatory approval.
Drove a company-wide risk-aware culture through continuous training, achieving 90%+ QA and compliance adherence across departments.
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