مطلوب للعمل لدى شركة ادوية الحكمة درجة البكالوريوس في الصيدلة أو الهندسة الكيميائية أو ما يعادلها

وصف الوظيفة:

Job description:

Job purpose:

To review and approve all documents related to Quality Assurance functions : change controls, deviations, CAPA and annual product review reports while overseeing and reviewing GMP areas processes and procedures to make recommendations for changes and/or improvements.

Key responsibilities:

• Recommends improvements to departmental policy and directs the implementation of procedures and controls covering all areas of Quality activity so that all relevant procedural/legislative requirements are fulfilled while delivering a quality, cost- effective service to customers.
• Supervises the day-to-day operations of Quality section to ensure that work processes are implemented as designed and comply with established policies, processes and procedures.
• Reviews and approves documents generated by the department, in order to provide approvals on deviations, Complaints, CAPA, and annual product review reports.
• Participates in quality risk management procedures, in order to manage and maintain the day-to-day change control process for product and process related information.
• Manages the creation and revision of batch record documents to support product development and product implementation.
• Oversight on the projects including new facility planning and construction of compounding equipment/facilities and system/process improvements to modify and optimize new product/process material qualifications.
• Participates in developing divisional procedures and guidelines to develop responses to corporate, regulatory, and third-party audits findings.
• Interacts with all plant departments to facilitate effective change control execution in order to meet the 2 Confidential anticipated timelines.
• Utilizes data from QA Trending for Deviations, CAPA, and Risk Assessment to identify and escalate Product Quality risk and monitor QA metrics as appropriate.
• Develops the Compliance (FDA six systems) function’s work plan and monitors workflow by reviewing and evaluating work methods and procedures to serve the department's goals and plans.
• Conducts gap analysis for Hikma functions actual and potential performance to facilitate harmonizing the system within the group.
• Notify production, planning and operations management of all rejects or Non-conforming products.
• Final release for product according to cGMP guidelines and authorities requirements

Qualifications & Experience:

      Minimum Qualifications:

      Bachelor’s degree in Pharmacy, Chemical Engineering, or equivalent with a master’s preferred.

      Minimum Experience:

      8-10 years relevant experience in pharmaceutical industry including at least 4-6 years in a Quality/Compliance role.

      At least 2 years of experience in a progressive managerial role.

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