QC & Microbiology Head – New Pharma Factory – Kuwait

1. Should be able to demonstrate strong understanding of USFDA/ MHRA/ EU or local guidelines.
2. Responsible for setting strategy direction for the entire Quality Control & Microbiology Department and team.
3. Conducts performance reviews for teams
4. Development, review, revise and implementation of Standard Operating Procedures (SOPs)/ Standard Test Procedures (STPs), validation protocols for as and when required.
5. Responsible for review and approval of method and product transfer documents/ reports to ensure compliance with all cGMP and all regulatory requirements.
6. Track compliance issues within all departments and ensure completion within defined timelines.
7. Timely release of finished products (sterility testing), incoming materials (Bacterial Endotoxin Testing, Bioburden) as and where necessary
8. Timely review and approvals of laboratory investigations, change controls and corrective and preventative action (CAPA), providing manufacturing support, record review/approval, and ongoing projects support (if any).
9. Manage and evaluate (trending) deviations, OOS/ OOT, Corrective Actions and Preventative Actions (CAPAs).
   Support team by guidance and coaching and provide direction/approval of activities and decisions.
10. Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews.
11. Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate
12. To monitor the sample management system and planning of testing of raw material, in process samples packing material and finish product.
13. To ensure the cGMP norms are followed while performing analysis.
14. Lead projects that impact the Quality Management System.
15. Report on progress against schedules, milestones and project goals, evaluate project resource needs and availability, identify and report gaps or project constraints, and develop solutions for successful implementation.

Skills

• Ability to manage handle a team of 10 to 35 colleagues.
• Familiarity with EMEA/MHRA; SFDA; USFDA
• Minitab or other Statistical Software (SPSS)
• SAP is a plus