Junior programozó állások, munkák minőségbiztosítás kategóriában

• Lead and develop the Product Risk Management team
• Own and continuously improve the risk management process according to ISOwithin our product development framework
• Ensure high-quality risk analyses and maintain consistent, audit-ready risk management documentation

• Collaborate with cross-functional teams including IT, Quality Assurance, and Operations to ensure documentation and validation of systems according to internal procedures
• Ensure compliance with internal and external regulatory requirements and guidelines
• Maintain the inventory of software applications

• Act as interface to the analytics representative
• Approve corrections in ProNas and create label data
• Prepare projects (special materials for aliquoting, check packing lists, folders, etc.)
• Assist with and execute trainings
• Issue reserve and stability samples
• Order laboratory materials

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

In your new role, you will define and implement the global strategy for analytical development, supporting BI's pipeline from early research through candidate characterization and selection to drug product development and launch....

• Increase the visibility and strategic importance of Quality Assurance across the company.
• Maintain, develop, and continuously improve the Quality Management System.
• Ensure compliance with current pharmaceutical regulations, GMP guidelines, and internal procedures.

QMS Process Management: Oversee the full lifecycle of changes for PTT owned QMS documents, from change initiation and action item assignment to responsible owners across the global network, driving completion and secure the final "approval to execute" before documentation is made effective...

• Author, own and maintain internal guidance and training documentation
• Collaborate with various functions within the global company, internal and external suppliers and with customers with the objective to share expertise and provide guidance

• Oversee work for timely completion of a complaint investigation and response to the various customers
• Communicate with customers regarding complaints, product issues and returned devices

• Drive innovation by evaluating and continuously advancing therapies through aerosol inhalation
• Communicate scientific insights effectively and foster strong interdisciplinary collaborations to ensure successful translation into clinical practice