ظائف شاغرة لدى شركة حكمة للادوية
ظائف شاغرة لدى شركة حكمة للادوية
تعلن شركة حكمة للادوية عن حاجتها الى :
Quality Compliance Manager
Job 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
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