Change Control Specialist (m/f)
Fast Track Diagnostics Luxembourg S.à r. l.
Hesperange, Luxembourg
il y a 19h
source : Monster

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause.

It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.

Sound interesting? Then come and join our global team as Change Control Specialist (m / f) Responsibilities : Review, provide collaborative feedback and approve change control requests Review all proposed changes for potential impact and coordinate follow-up Review all proposed changes, ensuring regulatory requirements are identified, reviewed and incorporated Hold the Change Advisory Board on a weekly base Maintain all change management documentation according to cGMP standards, including data integrity of paper and electronic records Generate monthly KPIs Troubleshoot and support the resolution of quality issues by fostering effective interdepartmental and cross-functional partnerships Deliver training on Change Management processes Work effectively with cross-functional teams, including with senior level and middle management, project management, QC, Production, Technical Support and Operations.

Provide routine communication to peers and cross-functional management on status of records and potential product quality impact concerns Perform all other tasks, projects and duties as assigned Be an active member of the Quality Transformation Program (QTP) for the Change Control process.

To find out more about the specific business, have a look at http : / / www.fast-trackdiagnostics.com / . Candidates profile : Education and working experience : Min.

Bachelor’s degree in Life Sciences Professional with minimum of 5 years of experience within a pharmaceutical, biopharma and / or biotech.

manufacturing environment Prior experience within Change Control Management in pharmaceutical industry is preferred, two (2) years Personal characteristics : Good technical writing capabilities Ability to multi-task / manage priorities Ability to collaborate with others, demonstrated interpersonal skills including flexibility and ability to work in a team environment, proven analytical abilities, and demonstrated written and verbal communication skills.

Excellent computer skills in Microsoft suite of products Word, Excel, Outlook. Proficiency in English both written and verbal communication and delivering presentations.

Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment Ability to work independently with minimal supervision, in addition to group / team setting.

Ability to complete tasks with accuracy and efficiency Portrays appropriate levels of integrity and professionalism. Ability to communicate effectively with management and staff Our global team : Siemens Healthineers is a leading global medical technology company.

50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our global team : Siemens Healthineers is a leading global medical technology company. 50,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare.

An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our culture : Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work.

We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success.

Check our Careers Site at http : / / www.fast-trackdiagnostics.com / career /

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