Working in the role you will be responsible for:

Supplier Qualification & Audits:
o Assess and qualify new suppliers/ vendors in accordance with GMP and company standards.
o Plan the annual external audit plan for suppliers/ vendors
o Plan, conduct, and document supplier audits to evaluate compliance with quality and regulatory requirements.
Supplier Management:
o Maintain and update the Approved Supplier List (ASL) and related documentation.
o Develop and manage quality agreements with suppliers to ensure mutual understanding of quality expectations and responsibilities.
o Monitor supplier performance through regular evaluations and key performance indicators (KPIs).
Quality Oversight:
o Review and approve supplier-related documentation, such as Certificates of Analysis (CoAs), material specifications, and validation reports.
o Manage deviations, non-conformances, and complaints related to supplier materials and services, ensuring timely resolution and root cause analysis.
o Ensure compliance with GMP and regulatory requirements throughout the supplier lifecycle.
Risk Assessment:
o Perform risk assessments related to supplier quality issues and their potential impact on the manufacturing process and product quality.
o Identify and mitigate risks within the supply chain through proactive measures.
Collaboration & Communication:
o Serve as the primary point of contact for suppliers on quality-related matters.
o Collaborate with internal departments (e.g., procurement, production, QA, and R&D) to address supplier-related issues.
o Support regulatory inspections and audits by providing supplier-related documentation and responses.
Continuous Improvement:
o Identify opportunities for process improvements in supplier quality management.
o Participate in cross-functional projects to enhance supplier quality systems.
Quality Assurance:
• Participate in the implementation and improvement of the Quality System and Integrated Management in the company according to the Guide of Good Manufacturing Practice for medicines for human use (GMP), and the ISO standards
• Perform internal and external audits as assigned
• Assist with writing, revising, and approving standard operating procedures
• Perform various risk assessments
• Elaborate quality agreements