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QUALIFICATIONS AND JOB DESCRIPTION
QUALIFICATIONS AND JOB DESCRIPTION
Minimum Requirements:
- University or Master's degree (Chemist, Chemical Engineering, Pharmacy, Biology)
- Min. 5 years’ experience in Quality Assurance
- Advanced English verbal and written communication skills
- High attention to detail
- Proficient in Microsoft Office Programs
- Proficient in Microsoft Outlook
- Knowledge of good documentation practices is preferred
- Having a good level of Quality Mindset.
Principal Duties and Responsibilities:
- We are looking for an experienced Quality Assurance Coordinator to oversee all aspects of quality management
- Ensuring compliance with current regulations
- Monitoring and reporting on all activities, processes, and procedures
- Assisting with the development of company policies, processes, and procedures.
- Providing departments with quality planning and support
- Manage printed materials design preparation with customers and RA teams
- Preparing and maintaining quality management documentation
- Provide expertise in validation& qualification ensuring compliance with current industry regulations, guidelines and trends
- Role responsibilities including but not limited to:
- Qualification of premises, equipment and utilities
- Computerised System Qualification
- Understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, 21CFR11, Annex11,etc.)
- Assist in supporting CSV and system process audits
- Assist in authorship, generation, and execution of validation documents (System Testing, IQ, OQ, PQ, UAT), for GxP regulated computerized systems
- Cleaning Validation
- Process Validation
- Ensure that all change controls are assessed for impact on Validation&Qualification
- Participate in Continuous Improvement programs.
- Participate in other projects as directed by the Quality Assurance Manager&QP
- Flexibility is important and responsibilities may change or other duties may arise for this position.
- Proactively work to ensure schedules are maintained.
- Build quality into all aspect of the operations by maintaining compliance to all quality requirements
- Report to Quality Manager & QP of the site
5 Nis 2024;
from:
kariyer.net