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وظائف شاغرة لتخصصات الصيدلة - الهندسة الكيميائية - الكيمياء لدى شركة MS Pharma


وظائف شاغرة لتخصصات الصيدلة - الهندسة الكيميائية - الكيمياء لدى شركة MS Pharma

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تعلن شركة MS Pharma عن حاجتها الى :

Corporate Quality Director 

Job Description and Requirements

Duties & Responsibilities:
  1. Develop, manage and control the Quality strategy, plans, SOPs, KPIs and ensure that QA, QC, and Validation’s goals and objectives are achieved.
  2. Monitor the workflow within the department and ensure that all preventive and corrective actions are being made promptly.
  3. Participate in developing corporate budgets and direct activities within the department towards achieving the set budget.
  4. Lead and manage the Quality department of all MS Pharma’s affiliate manufacturing facilities.
  5. Lead corporate Quality operations and compliance for MS Pharma’s affiliate manufacturing facilities including oral dosage forms, topical, and injectables.
  6. Lead the company’s inspection readiness for securing approvals of different regulatory authorities with focus on getting US FDA and EMA approval for all MS Pharma’s affiliate manufacturing facilities.
  7. Ensure compliance with all requirements and laws such as GMP and GLPs and ensure applying them in the analysis procedure.
  8. Develop, lead and implement the corporate Quality audit plan, to identify and alert top management on any critical quality threats and risks that may affect the company.
  9. Assess, monitor and report to top management the level of compliance across different affiliate companies and strategic third-party partners on regulatory requirements and quality related issues.       
  10. Ensure compliance of each affiliate to local regulatory requirements in each country MS Pharma operates in.
  11. Develop managerial and technical circulars within the department to achieve the set plans and objectives.
  12. Conduct periodic meetings with the team regarding work priorities and ensure work is flowing smoothly.
Requirements: 
  • BSc. Degree in Pharmacy, Chemical Engineering, Chemistry or other science-related majors.
  • A minimum of 15 years’ experience in the Pharmaceutical industry; experience in QMS and Quality management is a must, experience in production and QC will be of added value) 
  • Comprehensive experience in sterile and injectable manufacturing; aseptic manufacturing experience is a must. 
  • Extensive experience in US FDA and EMA regulations; experience in US-FDA & EMA approved facilities is preferred.
  • Experience in implementation of Quality by design & PAT initiative.
  • Excellent knowledge and practical experience in ICH, GLP, GAMP and WHO requirements.
  • Comprehensive knowledge and experience in ISPE guidelines.
  • Leadership and communication skills.
  • Proficiency in both written, spoken and read English and Arabic.

تعليقات

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