QC Head
Full time
at Mezzan Holding Co
in
Kuwait
Posted on March 28, 2024
Job details
- Should be able to demonstrate strong understanding of USFDA/ MHRA/ EU or local guidelines.
- Responsible for setting strategy direction for the entire Quality Control & Microbiology Department and team.
- Conducts performance reviews for teams
- Development, review, revise and implementation of Standard Operating Procedures (SOPs)/ Standard Test Procedures (STP's), validation protocols for as and when required.
- Responsible for review and approval of method and product transfer documents/ reports to ensure compliance with all cGMP and all regulatory requirements.
- Track compliance issues within all departments and ensure completion within defined timelines.
- Timely release of finished products (sterility testing), incoming materials (Bacterial Endotoxin Testing, Bioburden) as and where necessary
- 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).
- 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.
- Share oversight to individuals and team on personal development, performance, and quality related issues. Write and deliver performance reviews.
- Ensure proper use of assets, budget, and personnel and communicate effectively with key customers and partners, both within the site and outside as appropriate
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