Quality Assurance and Pharmacovi...
Mokattam, Cairo
Quality Assurance and Pharmacovigilance Manager
Mokattam, CairoPosted 20 days ago44Applicants for1 open position
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Job Description
- Establish, implement, and maintain a comprehensive Quality Management System (QMS) tailored to veterinary pharmaceutical Products.
- Ensure adherence to GMP and GDP standards across manufacturing, warehousing, and distribution.
- Manage deviations, change controls, , and product quality complaints related to veterinary drugs and biologicals.
- Conduct regular internal and external quality audits and follow up on corrective actions.
- Oversee supplier qualification and performance, including third-party logistics providers.
- Review and approve batch documentation to ensure product release readiness.
- Drive quality training programs for cross-functional teams to promote a culture of compliance and continuous improvement.
- Act as the Local Contact Person for Pharmacovigilance for veterinary products.
- Manage timely collection, documentation, and reporting of adverse events , product inefficacy, and other safety-related issues to local authorities and global PV teams.
- Maintain local pharmacovigilance procedures aligned with company global policies.
- Monitor product safety signals, prepare periodic safety reports, and coordinate responses to regulatory inquiries.
- Train commercial and technical teams on PV reporting responsibilities and compliance.
Job Requirements
- Bachelor’s degree in Pharmacy
- 10-12 years of experience in Quality Assurance and/or Pharmacovigilance within the pharmaceutical or veterinary health industry.
- Solid understanding of GMP, and GDP, with a preference for experience in veterinary medicine regulations.
- Strong documentation, auditing, and regulatory compliance skills.
- Proficient in English and Microsoft Office; experience with QMS or PV platforms is a plus.
- Excellent attention to detail and organizational skills.
- Clear communication and leadership abilities.
- Problem-solving mindset with a focus on quality and compliance.
- Ability to manage cross-functional collaboration and regulatory interactions.
