مطلوب مشرف امتثال الجودة لدى أدوية الحكمة في سحاب ، عمان ، الأردن

Job description:

Job purpose:

Supervising the implementation of APM Compliance function plans, as well as ensuring their compliance with APM /Sahab site rules and policies

Key responsibilities:

• Follows all relevant Compliance policies, processes, and standard operating procedures so that work is carried out in a controlled and consistent manner.
• Contributes to the preparation of the compliance budget to ensure alignment with the approved set budget.
• Implements the day-to-day operations assigned for the compliance to ensure compliance with the established standards and procedures.
• Supervises the activities and work of subordinates to ensure that all work within a specific area is carried out in an efficient manner and in compliance with the set policies, processes, and procedures.
• Complies with all relevant safety, quality, health, and environmental procedures to ensure a healthy and safe work environment.
• Hosting Regulatory Authorities and Corporate inspections within APM/Sahab site, as well as approving all inspection responses
• Managing and conducting internal audits to ensure compliance to cGMP
• Managing and conducting external audits to ensure the compliance of External service providers/ suppliers (e.g. Packaging Materials)
• Participating in quality risk management procedures
• Handling Field Alert Reports (FAR), complaints and products’ recall
• Handling cleaning validation system and coordination with relevant department and maintain the system up to date with guidelines and GMP practices
• Reviewing and approving documents generated by the Compliance, as well as following up on schedules/ plan/ work relevant to compliance department
• Conducting cGMP trends training
• Reviewing and approving Compliance relevant trending reports.
• Providing regulatory compliance guidance and policies for the company
• Performing other duties related to the job as assigned by the direct manager
• Generating, reviewing, and approving Quality Agreements.

Qualification & Experience:

• B.SC. degree in chemistry, chemical engineering or equivalent.
• 5 to 7 years of experience in the relevant field.
• Cleaning Validation Experience is a plus