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- Aufgaben: Lead quality compliance efforts and support teams in maintaining ISO/cGMP standards.
- Arbeitgeber: Join CONSULTYS, a human-sized consulting firm that values individual contributions and teamwork.
- Mitarbeitervorteile: Enjoy a full-time role with opportunities for professional growth in a diverse environment.
- Warum dieser Job: Be part of a cohesive team where your expertise directly impacts quality assurance in biotech.
- Gewünschte Qualifikationen: 5-10 years of QA experience in drug manufacturing or aseptic processing is required.
- Andere Informationen: Embrace a culture of diversity and inclusion while managing multiple projects.
Das voraussichtliche Gehalt liegt zwischen 54000 - 84000 € pro Jahr.
Senior Quality System Manager Consultant
As part of our development, we are recruiting a Senior Quality System Manager Consultant to join our teams.
Responsibilities:
- Verification of the company’s compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to GMP Part 1 and 2 or the EU Guidelines to GMP Medicinal Products for Human and Veterinary Use.
- Provide immediate support to operations and quality control staff to address compliance related concerns.
- Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams.
- Audit internal quality system elements in manufacturing and operational support areas.
- Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.
- Perform external audits of suppliers/vendors/off-site facilities.
- Act as a customer interface during on-site audits, conference calls and other standard means of communication.
- Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.
- Prioritize and manage a variety of projects simultaneously.
- May need to lead and direct the work of others. Review and approve validation documents.
- Review and Master Batch Records (MBR) and supporting documents.
- Perform review/release of batch records, as needed.
Your Profile:
- 5-10 Years Experience
- Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.
- GMP compliance and Part 11 compliance knowledge preferred.
- Experience with oversight of aseptic processing and the associated international aseptic processing regulations.
- Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic.
- The ability to interface and communicate directly with clients is required.
- Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.
Do you want to join the consulting world in a human-sized company that values the individual and performance?
To share your skills within a cohesive team where experiences are freely shared?
CONSULTYS is open to all talents and is committed to diversity and inclusion.
Seniority Level:
Associate
Employment Type:
Full-time
Job Function:
Quality Assurance
Industries:
Business Consulting and Services and Biotechnology Research
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Senior Quality System Manager Consultant Arbeitgeber: Consultys Suisse
Kontaktperson:
Consultys Suisse HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Quality System Manager Consultant
✨Tip Number 1
Familiarize yourself with ISO/cGMP quality system requirements and the PICS Guide to GMP. This knowledge will not only help you in interviews but also demonstrate your commitment to compliance and quality assurance.
✨Tip Number 2
Network with professionals in the quality assurance field, especially those with experience in aseptic processing and cell therapy manufacturing. Engaging with industry peers can provide insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've handled compliance-related concerns in past roles. Being able to articulate your experience with audits, change controls, and investigations will set you apart.
✨Tip Number 4
Showcase your communication skills by practicing how you would interact with clients during audits or meetings. Highlighting your ability to work independently while being team-oriented is crucial for this role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Quality System Manager Consultant
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Quality System Manager Consultant position. Understand the key responsibilities and required qualifications, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5-10 years of direct QA experience, particularly in commercial drug substance/drug product or aseptic processing. Use specific examples to demonstrate your expertise in GMP compliance and quality assurance.
Showcase Communication Skills: Since excellent written and oral communication skills are crucial for this role, ensure that your application materials are well-organized, clear, and free of errors. Consider including examples of how you've effectively communicated with clients or team members in past roles.
Tailor Your Application: Customize your cover letter to reflect your understanding of CONSULTYS's values, such as diversity and inclusion. Mention why you want to join a human-sized company and how you can contribute to a cohesive team environment.
Wie du dich auf ein Vorstellungsgespräch bei Consultys Suisse vorbereitest
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of ISO/cGMP quality system requirements and the PICS Guide to GMP. Be prepared to discuss specific examples from your experience that demonstrate your compliance knowledge.
✨Demonstrate Problem-Solving Skills
Prepare to share instances where you provided immediate support to operations and quality control staff. Discuss how you addressed compliance-related concerns and made independent quality-related decisions.
✨Highlight Your Audit Experience
Since auditing is a key responsibility, be ready to talk about your experience with internal and external audits. Share details about how you managed audit processes and interacted with clients during these audits.
✨Emphasize Communication Skills
Given the importance of communication in this role, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated with project teams and clients, especially in fast-paced environments.
