Quality Assurance Coordinator

EXELTİS İLAÇ SANAYİİ VE TİCARET A.Ş.

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