استخدام کارشناس QA
شرح موقعیت شغلی
● Getting to know the pharmaceutical industry and its processes.
● Getting to know the principles of GMP and quality management system.
● Proficient in quality assurance and documentation processes.
● Presence at the contracted production companies and continuously monitor the relevant activities that are being carried out.
● Follow up on the quality activities of the production unit to ensure that the related processes are being implemented according to the standards.
● Prepare all documents related to production as well as technology transfer documents of foreign contracting companies.
● Prepare, develop, gather, and archive all quality assurance-related documents.
● Raise and investigate the production deviations and change controls.
● Cooperate in preparing the CTD dossier for the production unit.
● Prepare the relevant SOPs as well as process indicators in order to constantly improve the performance of production units according to the standards.
● Cooperate in the assessment of the candidate companies to work with NEXUS which may have an impact on the quality of the company's products.
● Cooperate in periodical inspections of the production contracting companies to ensure that the GXP activities are properly handled and prepare the relevant reports.
● Identify and design general and specific methods of work to improve the organization's processes for the effectiveness of activities.
● Analyze data to identify areas for improvement in the quality system and development.
● Follow up on the quality activities of the production unit to ensure that the related processes are being implemented according to the standards.
● Prepare all documents related to production as well as technology transfer documents of foreign contracting companies.
● Prepare, develop, gather, and archive all quality assurance-related documents.
● Raise and investigate the production deviations and change controls.
● Cooperate in preparing the CTD dossier for the production unit.
● Prepare the relevant SOPs as well as process indicators in order to constantly improve the performance of production units according to the standards.
● Cooperate in the assessment of the candidate companies to work with NEXUS which may have an impact on the quality of the company's products.
● Cooperate in periodical inspections of the production contracting companies to ensure that the GXP activities are properly handled and prepare the relevant reports.
● Identify and design general and specific methods of work to improve the organization's processes for the effectiveness of activities.
● Analyze data to identify areas for improvement in the quality system and development.
مهارتهای مورد نیاز
- QA
- Validation
- GXP
- Microsoft Office
حداقل سابقه کار
- کمتر از سه سال
جنسیت
- مهم نیست
وضعیت نظام وظیفه
- معافیت تحصیلی معافیت دائم پایان خدمت