B&S Group
Quality / GDP Specialist
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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 facility and associated hubs in accordance with local requirements and ensuring product procurement, storage, and distribution are managed in accordance with GDP guidelines.
Supporting and maintaining 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 business and identifying opportunities for continuous improvement at all levels of our organization.
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Striving for a quality mindset where honesty, integrity, and compliance are at the heart of everything we do.
Ensuring KPIs, 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, approve, 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 responses to the audit observations, and implementation of CAPA’s to resolve audit findings.
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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 the correct environment for quality, safety, and security of product.
Ensuring products are transported as per labeled 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
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