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- Aufgaben: Lead the development of a quality management system for digital and hardware products.
- Arbeitgeber: Join a cutting-edge company focused on digital solutions in various industries.
- Mitarbeitervorteile: Enjoy remote work flexibility with occasional onsite visits.
- Warum dieser Job: Be part of a project that enhances quality standards and compliance in innovative tech.
- Gewünschte Qualifikationen: Experience in quality management systems and knowledge of GxP or 21 CFR Part 11 is essential.
- Andere Informationen: This freelance role starts on January 13, 2025, for approximately 7 months.
Das voraussichtliche Gehalt liegt zwischen 60000 - 84000 € pro Jahr.
Digital QMS Expert – Pharma (m/f/n) – FREELANCE
Description
A digital platform has been developed that provides services to create digital twins of physical objects, which can then be used to authenticate physical objects along the value chain in various industries.
The focus of this project is to introduce a quality management system (QMS) for the digital part of the portfolio. The goal is to ensure the highest standards of quality for digital solutions and devices, improving efficiency and compliance in the overall system.
Tasks:
- Reviewing the current quality measures for software and digital products, as well as their development processes, and proposing improvements.
- Introducing a quality management system for the entire project, including hardware components such as handheld reader devices (scanners).
- Assessing whether GxP or 21 CFR Part 11 compliance is required for the project.
- The objective of this project is to establish and implement a comprehensive quality management system that ensures the highest standards of quality for both digital and hardware products.
Additional Information:
Start: 13.01.2025
Duration: ca. 7 months
Capacity: Fulltime
Location: Remote (ca. 2 visits onsite)
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Digital QMS Expert – Pharma (m/f/n) – FREELANCE Arbeitgeber: OC Recruitment GmbH & Co. KG
Kontaktperson:
OC Recruitment GmbH & Co. KG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Digital QMS Expert – Pharma (m/f/n) – FREELANCE
✨Tip Number 1
Make sure to familiarize yourself with the latest trends and regulations in digital quality management systems, especially in the pharmaceutical industry. This knowledge will not only help you during the interview but also demonstrate your commitment to staying updated in this rapidly evolving field.
✨Tip Number 2
Network with professionals who have experience in implementing QMS in digital environments. Engaging with industry experts can provide you with valuable insights and potentially lead to referrals that could strengthen your application.
✨Tip Number 3
Prepare to discuss specific examples from your past experiences where you successfully improved quality measures or implemented a QMS. Highlighting tangible results will showcase your expertise and problem-solving skills.
✨Tip Number 4
Since this role involves remote work with occasional onsite visits, be ready to articulate how you manage communication and collaboration in a remote setting. Demonstrating your ability to work effectively in a distributed team will be crucial.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Digital QMS Expert – Pharma (m/f/n) – FREELANCE
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Digital QMS Expert in the Pharma industry. Familiarize yourself with quality management systems, GxP, and 21 CFR Part 11 compliance to tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience with quality management systems, particularly in digital solutions and hardware components. Provide specific examples of past projects where you improved quality measures or compliance.
Showcase Technical Skills: Detail your technical skills related to software and digital product development processes. Mention any tools or methodologies you are proficient in that are relevant to establishing a QMS.
Craft a Strong Cover Letter: Write a compelling cover letter that outlines your motivation for applying and how your expertise aligns with the goals of the project. Be sure to express your understanding of the importance of quality in both digital and hardware products.
Wie du dich auf ein Vorstellungsgespräch bei OC Recruitment GmbH & Co. KG vorbereitest
✨Understand Quality Management Systems
Make sure you have a solid grasp of quality management systems, especially in the context of digital products and GxP compliance. Be prepared to discuss your experience with QMS and how it can be applied to both software and hardware components.
✨Showcase Your Problem-Solving Skills
Be ready to provide examples of how you've identified quality issues in past projects and the steps you took to resolve them. Highlight your ability to propose improvements to existing processes, as this will be crucial for the role.
✨Familiarize Yourself with Regulatory Standards
Research GxP and 21 CFR Part 11 compliance requirements. Demonstrating your knowledge of these regulations will show that you understand the importance of compliance in the pharmaceutical industry.
✨Prepare for Remote Collaboration
Since the position is remote with occasional onsite visits, think about how you can effectively communicate and collaborate with a team in a virtual environment. Share any relevant experiences you have with remote work and tools you’ve used to maintain productivity.
