Duties & Responsibilities:
- Develop, manage and control the Quality strategy, plans, SOPs, KPIs and ensure that QA, QC, and Validation’s goals and objectives are achieved.
- Monitor the workflow within the department and ensure that all preventive and corrective actions are being made promptly.
- Participate in developing corporate budgets and direct activities within the department towards achieving the set budget.
- Lead and manage the Quality department of all MS Pharma’s affiliate manufacturing facilities.
- Lead corporate Quality operations and compliance for MS Pharma’s affiliate manufacturing facilities including oral dosage forms, topical, and injectables.
- 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.
- Ensure compliance with all requirements and laws such as GMP and GLPs and ensure applying them in the analysis procedure.
- 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.
- 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.
- Ensure compliance of each affiliate to local regulatory requirements in each country MS Pharma operates in.
- Develop managerial and technical circulars within the department to achieve the set plans and objectives.
- 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.
