We are looking for a Quality Assurance Specialist for our Quality Department in Dubai. In this new position, you will be part of projects and activities linked to our quality management system and You will be reporting to Regional QPPV & Quality Manager.
Your main tasks and requirements are:
- Quality management systems QMS i.e. setting a local quality manual, procedures based on global CSL Vifor processes.
- Setting contractual obligation for quality with service provider in distribution
- Managing products complaints, issues, deviations, CAPA and recalls when occurred.
- Ensuring training of local Affiliate on the QMS and using Learning Management software LMS
- Inspection readiness program and support during Health authorities’ inspection in MENA region
- Manage deviations and incidents; investigations in the Distribution, Supply Chain, Warehouse and global CSL manufacturing sites.
- Ensure the establishment, review, approval of compliance reports
- Follow-up of deviations related to these records
- Define appropriate corrective and preventive actions and monitor them
- Change control Management, Documentation Management and Complaints Management
- Follow up Product Quality Review reports with local Manufacturers
- Involved in Review/approval of Transport deviation and product release with distributors
- Supplier’s audits and Internal Audits
- Participate in setting Quality Objective and continuous Quality improvement projects
- Ensure the compliance of the quality management system with CSL global objective and set up Quality Management review meeting and reports to top management meetings outcome
- Provide GDP/GMP training to all collaborators
- Support continuous improvement and Operational Excellence initiatives
- Implement Risk management principles
- Experience in writing audit reporting and Temperature Mapping reviews
For this interesting role, we are looking for a rigorous person bringing the following profile:
- A health, life sciences, or medical science degree; or equivalent by experience
- Minimum 3 years of pharmaceutical industry experience
- Knowledge of GxP systems & requirements
- Understanding of GxP principles, concepts, practices & standards
- Understanding of risk management
- Ability to communicate effectively verbally and in writing,
- Excellent written & spoken English.
- Proficient in Good Documentation Practices
- Excellent Word processing, Power Point Presentation & Excel application skills
- Knowledge of commercialization and business practice
- Ability to learn new computer interface systems
- Conducting audits
You describe yourself as a person with very good communication and organizational skills. You like to work independently and effectively in multidisciplinary teams. Then we look forward to receiving your application in English.