– it állások Budapesten (egészségügy, gyógyszeripar)

• 3 főből álló csoport vezetése, irányítása, a napi feladatok szervezése, koordinálása, monitorozása
• Együttműködés és folyamatos kapcsolattartás a minőségirányítási és más szakmai területekkel (laborok, telephelyi minőségbiztosítási szervezetek, IT és külsős partnerek, fejlesztők)

• Lead and coordinate the daily work of the Quality Control Assistant team 
• Ensure quality compliance during production through checks and documentation review 
• Identify, document, and escalate deviations and quality issues in cooperation with QA and Qualified Person 

• Utilize clinical information in safety database to provide company causality assessment and comment.
• Review case reports for medical accuracy, including validation of adverse event listedness and coding consistency.
• Request follow-up information for robust case causality assessment.

Monitors CSR’s performance on a daily basis, by taping, listening to, reviewing and evaluating calls...

• Lifecycle management of approved regulatory files
• Documentation support in registration and renewal procedures
• Preparation of ASMF/DMF/CEP according to project timelines, ensuring compliance with regulatory requirements and facilitating submissions to the Authorities

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

Overseeing lifecycle validation of computer systems to ensure compliance with global regulatory standards Providing strategic leadership in developing validation frameworks Managing risk-based testing strategies Ensuring IT systems are fit for intended use and maintain data integrity Developing and...

Elicitation of business needs through stakeholder workshops Creation of User Requirements Specifications (URS) and Functional Specifications (FS) Development and maintenance of Requirements Traceability Matrix (RTM) Impact assessment of proposed system changes on validated state Assistance in...

Project Planning Project Management Vendor and Contract Management Coordination of Project Team Members Risk Management Project Administration...

Regional representation within assigned territory Development of personalized action plans for key opinion leaders and decision-makers Visiting physicians to maintain and increase product use Planning and coordinating roundtable discussions, group meetings, local symposia, professional exhibitions,...