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Kuwait City

    QC Head - Kuwait City, الكويت - Mezzan Holding Co

    Mezzan Holding Co
    Mezzan Holding Co Kuwait City, الكويت

    منذ 4 أيام

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    وصف
    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 (STP's), 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
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