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- Aufgaben: Lead internal audits for CAPEX projects, ensuring compliance with GMP standards.
- Arbeitgeber: Join a global bio-pharmaceutical company based in Switzerland, dedicated to quality and innovation.
- Mitarbeitervorteile: Enjoy a dynamic work environment with opportunities for professional growth and development.
- Warum dieser Job: Be a key player in maintaining product quality and regulatory compliance in exciting new projects.
- Gewünschte Qualifikationen: Experience in auditing and knowledge of GMP standards are essential.
- Andere Informationen: This role is crucial for ensuring the integrity of new facilities and operations.
Das voraussichtliche Gehalt liegt zwischen 48000 - 72000 € pro Jahr.
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Client:
EPM Scientific
Location:
Switzerland
Job Category:
Other
Job Reference:
001ac36e520d
Job Views:
3
Posted:
12.05.2025
Expiry Date:
26.06.2025
Job Description:
We are currently searching for a QA Auditor (Capex projects) for a global bio-pharmaceutical company located in Switzerland.
Responsibilities:
- Lead and Co-Auditor:
- Plan and conduct detailed internal audits for ongoing CAPEX projects to ensure compliance with GMP.
- Document and report findings, managing follow-up actions to address non-compliance issues.
- Review and monitor C&Q plans to verify they meet all required GMP standards.
- Ensure thorough execution of C&Q activities, confirming alignment with approved protocols.
- Design and Zone Concept:
- Audit design plans to ensure they adhere to GMP, focusing on layout, material flow, and contamination control.
- Evaluate zone concepts for proper segregation and risk management.
- Compliance with GDOCP and Data Integrity:
- Verify the integrity and completeness of the General Document of Certified Product.
- Oversee data management practices to ensure all data complies with GMP and Data Integrity standards.
- Guarantee Compliance: Ensure all CAPEX projects comply with GMP standards, emphasizing design integrity and operational effectiveness.
- Maintain Regulatory Standards: Lead efforts to align projects with industry regulations and internal quality benchmarks.
This role is pivotal in ensuring that new facilities are built and operated in compliance with stringent GMP requirements, safeguarding product quality and regulatory adherence.
For further information about this position, please apply with your CV.
*Please note, only those with the right to work in Switzerland can apply!
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QA Auditor (Capex projects) Arbeitgeber: TN Switzerland
Kontaktperson:
TN Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: QA Auditor (Capex projects)
✨Tip Number 1
Familiarize yourself with GMP standards and regulations specific to the bio-pharmaceutical industry. Understanding these guidelines will not only help you in the interview but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the bio-pharmaceutical field, especially those involved in CAPEX projects. Engaging with industry experts can provide insights into current trends and challenges, making you a more informed candidate.
✨Tip Number 3
Prepare to discuss specific examples of past audits you've conducted, particularly those related to CAPEX projects. Highlighting your hands-on experience will showcase your ability to lead and co-audit effectively.
✨Tip Number 4
Stay updated on the latest developments in data integrity practices and compliance technologies. Being knowledgeable about these areas will position you as a forward-thinking candidate who can contribute to maintaining high standards.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: QA Auditor (Capex projects)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities of a QA Auditor in Capex projects. Familiarize yourself with GMP standards and the specific requirements mentioned in the job description.
Tailor Your CV: Customize your CV to highlight relevant experience in conducting audits, compliance with GMP, and any previous work with CAPEX projects. Use keywords from the job description to make your application stand out.
Craft a Strong Cover Letter: Write a compelling cover letter that explains why you are a great fit for this role. Mention your experience with internal audits, data integrity, and regulatory compliance, and how these align with the company's needs.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial for a QA Auditor.
Wie du dich auf ein Vorstellungsgespräch bei TN Switzerland vorbereitest
✨Understand GMP Standards
Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and how they apply to CAPEX projects. Be prepared to discuss specific examples of how you've ensured compliance in past roles.
✨Showcase Your Audit Experience
Highlight your experience with internal audits, especially in the bio-pharmaceutical sector. Discuss your approach to planning and conducting audits, and how you document and report findings effectively.
✨Familiarize Yourself with C&Q Plans
Review the concepts of Commissioning and Qualification (C&Q) plans. Be ready to explain how you would verify that these plans meet GMP standards and ensure thorough execution.
✨Emphasize Data Integrity
Prepare to discuss your understanding of data management practices and how you ensure data integrity in compliance with GMP. Share any relevant experiences where you maintained high standards of data quality.
