Thembeka Mnisi

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Vendor Support Specialist (Medior) - P95

(2025-10)

• Manage vendor qualification processes, reviewing certifications (ISO, GCP, GLP, GMP) and assessing compliance with regulatory and company standards.
• Maintain and update vendor documentation including GMP certificates, quality agreements, licences, SOPs, and audit records to ensure an accurate and current compliance database.
• Monitor ongoing vendor performance, identify non-conformities, escalate issues to stakeholders, and track corrective and preventive actions (CAPAs) to closure.
• Coordinate and support external vendor audits and internal quality assessments, including preparation, documentation review, report compilation, and follow-up with vendors.
• Oversee updates to the approved vendor list in accordance with change control processes and SOP requirements.
• Draft and update SOPs related to vendor management processes; deliver training to internal staff on applicable procedures and compliance expectations.
• Support QA activities by liaising with laboratories, resolving analytical queries, and providing documentation needed for QA batch reviews or regulatory requests.
• Contribute to process improvement initiatives, ensuring that vendor compliance activities align with internal quality standards, regulatory expectations, and audit readiness.

Technical Support Specialist (Medior) - P95

(2024-09 - 2025-09)

• Conduct vendor qualification assessments, review lab manuals, evaluate computer systems, participate in proposal submissions, develop SOPs, support technical and operational teams, and ensure alignment between vendors and project needs.
• Manage vendor qualification processes, reviewing certifications (ISO, GCP, GLP, GMP) and assessing compliance with regulatory and company standards.
• Maintain and update vendor documentation including GMP certificates, quality agreements, licences, SOPs, and audit records to ensure an accurate and current compliance database.
• Monitor ongoing vendor performance, identify non-conformities, escalate issues to stakeholders, and track corrective and preventive actions (CAPAs) to closure.
• Coordinate and support external vendor audits and internal quality assessments, including preparation, documentation review, report compilation, and follow-up with vendors.
• Oversee updates to the approved vendor list in accordance with change control processes and SOP requirements.
• Draft and update SOPs related to vendor management processes; deliver training to internal staff on applicable procedures and compliance expectations.
• Support QA activities by liaising with laboratories, resolving analytical queries, and providing documentation needed for QA batch reviews or regulatory requests.
• Contribute to process improvement initiatives, ensuring that vendor compliance activities align with internal quality standards, regulatory expectations, and audit readiness.

Technical Support Specialist - OnQ Research

(2022-11 - 2024-08)

• Provide system support, vendor data tracking, operational coordination, and administrative support for clinical studies.
• Conduct vendor qualification assessments, review lab manuals, evaluate computer systems, participate in proposal submissions, develop SOPs, support technical and operational teams, and ensure alignment between vendors and project needs.
• Manage vendor qualification processes, reviewing certifications (ISO, GCP, GLP, GMP) and assessing compliance with regulatory and company standards.
• Maintain and update vendor documentation including GMP certificates, quality agreements, licences, SOPs, and audit records to ensure an accurate and current compliance database.

Medical Laboratory Scientist - Unistel Medical Laboratories

(2021-01 - 2022-11)

• Ensured quality control and adherence to GLP protocols in cytogenetic testing. Maintained audit-ready documentation and collaborated with QA for process alignment.
• Participated in diagnostic accuracy assessments and data validation. Perform chromosomal analysis, quality control, report generation, and ensure laboratory compliance with GLP standards.

Clinical Trial Recruiter - SubjectWell

(2018-11 - 2019-07)

Patient screening, trial matching, informed engagement, documentation, and clinical trial support.

BHSc - Medical Laboratory Sciences