EXELTİS İLAÇ SANAYİİ VE TİCARET Staj Başvurusu – Quality Assurance Coordinator

EXELTİS İLAÇ SANAYİİ VE TİCARET Staj Başvurusu – Quality Assurance Coordinator staj başvurusu, stajyer, staj ilanıdır.

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