وظائف في الاردن

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

للتقديم من خلال الضغط على الصورة

للتقديم على الوظيفة اضغط هنا

مقالات ذات صلة

اترك تعليقاً

لن يتم نشر عنوان بريدك الإلكتروني. الحقول الإلزامية مشار إليها بـ *

زر الذهاب إلى الأعلى