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    Technician - Engineering - Dubai, United Arab Emirates - Jumeirah Hotels and Resorts

    Jumeirah Hotels and Resorts
    Jumeirah Hotels and Resorts Dubai, United Arab Emirates

    3 days ago

    Default job background
    Description
    Allen Spolden is actively recruiting for a Director of Quality. This is a perm (Direct Hire) opportunity. Relocation assistance will be provided.

    Location: Gulfport, MS (100% onsite is required.)
    Work Schedule: M-F, flexible start
    Salary: Dependent on experience.

    Job Summary:

    The Director of Quality is responsible for developing, implementing, and maintain a cGMP Quality System to meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and customer expectations.

    Supervisory Responsibilities:

    • Oversee all Quality departments.
    • Provide support to all Quality departments.
    • Interview, hire, and train new staff.
    • Provide constructive feedback and retraining as needed.
    • Handles discipline of employees in accordance with company policy.

    Duties/Responsibilities:

    To establish the quality system.

    • Establish the quality management system to describe how the firm complies CGMPs and operates to maintain a state of control.
    • Keep current with good industry practices, and applicable to the mission of your operation.

    To audit compliance to the quality system.

    • Audit for compliance to policies and procedures.
    • Report on the performance of the quality system that help

    decision making for targeted actions.

    To establish procedures and specifications.

    • Ensure that procedures and specifications are appropriate and followed.
    • Ensure that the procedures and specifications of firms under contract are also appropriate and followed, i.e., maintain control and take responsibility for third-party services providers (contract manufacturers, contract laboratories, etc.).

    To establish manufacturing controls.

    • Ensure that appropriate manufacturing in-process controls are implemented.
    • Ensure in-process controls are performed during manufacturing operations and results are satisfactory.

    To review and approve or reject all things cGMP related.

    • Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications including changes to these documents.
    • Review and approve/reject reprocessing and rework procedures.
    • Review and approve/reject production batch records and make the final decision to release a product lot into commerce.

    To ensure investigation of nonconformance.

    • Ensure investigation is conducted and root cause is eliminated for production and control record errors, discrepancies, and failure to meet specification, including quality attributes.
    • Review and investigate consumer complaints.

    To keep management informed.

    • Report on product, process and system risks.
    • Report on outcome of regulatory inspections and ensure responses are complete and managed to verifiable closure.

    To describe responsibilities in writing.

    • Have a complete and compliant procedure that describes responsibilities.
    • Follow the procedure.

    To remain independent.

    • Ensure there is no conflict of interest between regulatory responsibilities and actual daily activities.
    • Be independent reviewer and approver with respect to manufacturing and process/product development units.

    Required Skills/Abilities:

    • Excellent verbal and written communication skills in English.
    • Excellent management and teamwork skills.
    • Excellent organizational skills and attention to detail.
    • Excellent time management skills with a proven ability to meet deadlines.
    • Ability to function well in a high-paced and at times stressful environment.
    • Ability to understand and follow all Standard Operating Procedures and current Good Manufacturing Practices provided by the Company.
    • Understanding of quality systems including change control, deviations and CAPAs.
    • Ability to handle multiple tasks concurrently and complete them in a timely manner.
    • Strong written and verbal language skills to effectively read and write SOPs and related lab reports, and communicate with personnel at all levels in the organization.

    Education and Experience

    • B.S. in Chemistry, Biology, or a related discipline.
    • Experience in computer software, such as Microsoft applications.
    • Expert knowledge of cGMP regulations.
    • Expert knowledge and understanding of FDA policies and regulations.
    • 10+ years of management experience in a pharmaceutical manufacturing setting.
    • Pharmaceutical experience required.

    Benefits:
    • Dental insurance
    • Flexible schedule
    • Health insurance
    • Life insurance
    • Paid time off
    • Relocation assistance
    • Vision insurance


    Requirements

    • Quality: 10 years
    • FDA regulations: 5 years
    • cGMP Experience: 5 years
    • WIlling to relocate to Gulfport, MS is required.


    Benefits

    Benefits:

    • Dental insurance
    • Flexible schedule
    • Health insurance
    • Life insurance
    • Paid time off
    • Relocation assistance
    • Vision insurance


    Quality: 10 years FDA regulations: 5 years cGMP Experience: 5 years WIlling to relocate to Gulfport, MS is required.
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