Loading...
 
Apply now »

Title:  Quality Compliance Manager

Description: 

Job Accountabilities

- Host inspections and approve audit responses

- Contact and respond to all regulatory authorities for any requirements

- Maintain the approval from all authorities by implementing quality culture awareness to ensure readiness for any external inspection

- Review, evaluate and approve all documents generated at the quality compliance department (Complaint, Recall, site master file, SOPs, annual product review, …)

- Review agreements

- Develop and update the quality compliance system and plan for department improvement and follow up on the actual achievement vs. the department KPIs

- Satisfy needs for the customer and coordinate with them efficiently (QC, production, WH, maintenance, validation, QA, regulatory, sales and marketing, other Hikma sites, etc.)

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

- Ensuring that work activities are carried out achieving the pre-set performance goals, and suggesting any necessary actions to the direct supervisor

- Developing the Departments function’s work plan; assigning work activities, projects, and programs, monitoring workflow, reviewing and evaluating work methods and procedures, and directing such activities to serve the Department's goals and plans

- Proposing plans and programs that boost the effectiveness of the departments’ function-

Hosting Regulatory Authorities and Corporate inspections within APM site, as well as approving all inspection responses

- Perform internal audit for all quality systems and departments

- Participating in quality risk management procedures

- Reviewing and approving documents generated by the department, as well as following up on schedules/plans/ work relevant to the department

- Reviewing and approving deviation, CAPA, and annual product review reports.

- Providing regulatory compliance guidance and policies for the company

- Generating, reviewing, and approving Quality Agreements

- Developing, maintaining, and updating the quality system as per GMP.

- Establishing clearly defined quality assurance standards and procedures based on international guidelines and regulations that ensure compliance of processes with GMP and quality standards

- Performing other duties related to the job as assigned by the direct supervisor

 

 

Qualifications:

- BSc in sciences or higher with enough experience in USFDA regulations

preferable if the candidate was working in a USFDA /EU certified pharmaceutical company with at least 3 years of experience as a compliance manager

- Excellent communication and leadership skills

- Computer skills

- Excellent Arabic and English languages

- Full understanding of the regulatory guidelines and latest requirements

- Planning & Organizing Skills

Location: 

As-Salt, JO

Apply now »