Quality Assurance GDP Specialist

Supporting the Wholesale Distribution / Sales and Operations Team

* Meet our customers’ and patients’ needs by providing products and services with the right quality on time every time, ensuring compliance with regulatory requirements.

* Provide QA oversight of all GDP activities at the faciliy and asscoaited hubs in accordance with local requirements and ensuring product procurement, storage and distribution are managed in accordance with GDP guidelines.

* Supporting and maintenance of QMS activities, which includes deviations, change controls, CAPA’s, complaints and ensuring timely completion and compliance to QMS elements.

* Promoting a Good Quality Culture within the businesss. and to identify opportunities for continuous improvement at all levels of our organisation.

* Striving for a quality mindset where honesty, integrity and compliance are at the heart of everything we do.

* Ensuring KPI’s, targets are met and communicate with Management during Quality Management Review (QMR).

* Review and approval of impact assessments, root cause analysis investigations and Executive summary reports for deviations.

* Maintain, review and approval and improve SOP’s, Work Instructions for QA and distribution related activities ensuring compliance with GDP regulations.

* Performing Supplier and customer Qualifications, negotiation and management of Quality Technical Agreements (QTA’s).

* Leading on-site client and regulatory audits, submitting of responses to the audit observations and implementation of CAPA’s to resolve audit findings.

* Scheduling and conducting of Self-inspections.

* Handling of Recalls, Falsified medicines and customer returns.

* Ensuring storage areas are qualified, validated, mapped as per guidelines to maintain correct environment for quality, safety and security of product.

* Ensuring products are transported as per labelled storage conditions in dedicated vehicles and protecting from theft, breakage and adulteration.

* ESSENTIAL EXPERIENCE, SKILLS, AND ABILITIES:

* Degree in scientific discipline

* Minimum 5+ years of experience in Quality Assurance / GDP

* Knowledge of Quality Compliance requirements