Experienced pharmacist with demonstrated history of working in pharmaceutical Human solid dosage form , liquid and semisolid manufacturing & Veterinary Vaccine Manufacturing.
Skilled in pharmaceutical quality management , cGMP inspection, Validation and operation
• Leading Klybeck team for SFDA GMP Audit preparation for new Vaccine Plant.
• Oversee all levels of staff activity and performance and ensuring that all operations are in compliance with cGMP requirements.
• Provide direction and leadership for all site operations including but not limited to: Manufacturing, Quality Operations, Materials Management, Process Validation activities, Engineering and EHS.
• Screen, interview and manage the onboarding process of new hires
• Communicate effectively with various stakeholders, including but not limited to other areas within the company’s supply network, external suppliers, SFDA, Modon,Ministry of Investment and other governmental organizations.
1. Ensuring that all operations are in compliance with cGMP requirements.
2. Final approval of suppliers of raw materials and packaging materials.
3. Final approval for Technical outsourcing agreements.
4. Final approval of main modification & adjustment of buildings and production lines and products components.
5. Internal and External audit team leader.
6. Approval of Job description of key personnel.
7. Responsible of recall and complaints of products and coordination with relevant departments to ensure application of corrective actions. 8. Final approval of technical documents submitted for registration in SFDA.
• Team leader of Med City Pharma SFDA GMP Audit preparation for new manufacturing area , building Quality system from scratch with technical team (Area/Machinery-equipment's evaluation qualification and calibration/ Documentation preparation including SOPs, Forms, Policy, Specification and Quality system including cleaning validation and process validation).
• Provide leadership for Technical & development team members.
• Supervises and monitors performance of technical team members.
• Coordinates activities within Manufacturing and Quality Department to manage production schedules ensuring highest quality standards, and safety issues.
GMP Audit
Leadership
Technical reporting