About You
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:
Minimum Requirements
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
Communication skills
Ability to communicate effectively verbally and in writing,
Excellent written & spoken English.
Proficient in Good Documentation Practices
Computer skills
Excellent Word processing, Power Point Presentation & Excel application skills
Preferred Requirements
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.
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