Quality Assurance Manger
Banisama Pharma
- Kabul
- Permanent
- Full-time
- Develop and maintain a prequalification framework for suppliers, products, and service providers.
- Conduct supplier audits, document reviews, and capability assessments.
- Maintain and update an approved supplier and product list.
- Collaborate with procurement and regulatory teams to ensure compliant sourcing.
- Review and approve technical documentation for imported and locally sourced products.
- Lead risk assessments and prequalification reports for new vendors or products.
- Ensure implementation of the company's Quality Management System (QMS).
- Oversee quality audits, inspections, and self-assessments.
- Ensure that all Standard Operating Procedures (SOPs) are in place, current, and followed.
- Manage deviation reporting, CAPA, change control, and product complaints.
- Supervise and mentor QA personnel.
- Ensure proper training programs are developed and implemented for quality staff.
- Review and approve batch records, quality reports, and release documentation.
- Check all the consignments received in the warehouse and fill in the required GRNs and complete the checklist.
- Issue the release order of goods from arrival area (if all is good) to the saleable stock.
- Complete the necessary procedure for products that need to be quarantined or investigated.
- Provide strategic input to senior management on quality and supplier risk.
- Develop departmental budgets, plans, and KPIs.
- Participate in cross-functional meetings to align quality and procurement objectives.
- Maintain up-to-date knowledge of relevant international standards and regulatory requirements (e.g., WHO, ISO, FDA, EMA, local MOH).
- Bachelor's degree in Pharmacy, Chemistry, Life Sciences or related field.
- Minimum 3-4 years of experience in pharmaceutical quality assurance or supplier qualification.
- Experience in auditing, risk assessment, and regulatory compliance.
- Proven experience in managing teams and cross-functional collaboration.
- Strong knowledge of GMP, GDP, ISO 9001, and other regulatory standards.
- Ability to write and review detailed technical and quality documentation.
- Self-motivated, results-driven, and independent thinking.