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- Aufgaben: Join us as a Quality Assurance Architect Consultant, focusing on aseptic training and compliance.
- Arbeitgeber: Consultys Switzerland has over 19 years of experience in biotech and pharma consulting.
- Mitarbeitervorteile: Enjoy a supportive work culture with a focus on respect, recognition, and transparency.
- Warum dieser Job: Be part of a dynamic team that values individual contributions and fosters professional growth.
- Gewünschte Qualifikationen: 4+ years in the industry with expertise in aseptic processing and EU GMP compliance required.
- Andere Informationen: Fluency in English and German is essential; we embrace diversity and inclusion.
Das voraussichtliche Gehalt liegt zwischen 48000 - 84000 € pro Jahr.
Direct message the job poster from Consultys Suisse
For more than 19 years, through our consulting and engineering activities, we have supported our clients throughout the entire lifecycle of biotechnology, pharmaceutical and device products.
Part of an organization of more than 750 Life-science experts, Consultys Switzerland supports and develops talented individuals recognized for their technical and scientific expertise. Our activities allow us to be present in both French-speaking and German speaking Switzerland, with agencies in Lausanne and Basel.
At Consultys, we’re proving that it’s possible to combine people and performance.
Much more than concepts, our 3 values „Respect, Recognition and Transparency“ guide us and are the foundation of our history, the heart of our group’s success.
As part of our development, we are recruiting a Quality Assurance Architect Consultant to join our teams in Bern.
- Supports creation and implementation of the aseptic operator training program for the site
- Creation and update of procedures and risk assessments
- Ensures adherence to global procedures and standards
- Creation of SOPs in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
- Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
- Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)
Your profile:
- Minimum 4 years of experience in the industry
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance.
- Experience in the pharmaceutical manufacturing industry, specifically aseptic processing
- Demonstrated experience in quality assurance and regulatory compliance with EU GMP Annex
- Fluent in both English and German
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
Biotechnology Research and Pharmaceutical Manufacturing
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Aspetic QA Expert Consultant Arbeitgeber: Consultys Suisse
Kontaktperson:
Consultys Suisse HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Aspetic QA Expert Consultant
✨Tip Number 1
Make sure to familiarize yourself with the specific regulations and standards related to aseptic processing and EU GMP Annex. This knowledge will not only help you in interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the biotechnology and pharmaceutical industries, especially those who have experience in quality assurance roles. Engaging with them can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences in detail, particularly any projects related to aseptic processes or training programs. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Since Consultys values respect, recognition, and transparency, be ready to share examples of how you've embodied these values in your previous roles. This alignment with their company culture can strengthen your application.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Aspetic QA Expert Consultant
Tipps für deine Bewerbung 🫡
Understand the Company Values: Familiarize yourself with Consultys' core values: Respect, Recognition, and Transparency. Reflect these values in your application to show that you align with their company culture.
Highlight Relevant Experience: Emphasize your minimum 4 years of experience in the industry, particularly in sterility assurance and aseptic processing. Provide specific examples of your work in quality assurance and regulatory compliance.
Showcase Language Proficiency: Since fluency in both English and German is required, make sure to mention your language skills prominently in your CV and cover letter. If applicable, provide examples of how you've used these languages in a professional context.
Tailor Your Application: Customize your CV and cover letter to reflect the specific requirements of the Quality Assurance Architect Consultant role. Address how your skills and experiences directly relate to the responsibilities outlined in the job description.
Wie du dich auf ein Vorstellungsgespräch bei Consultys Suisse vorbereitest
✨Showcase Your Technical Expertise
Be prepared to discuss your experience in sterility assurance and aseptic processing. Highlight specific projects or challenges you've faced in the pharmaceutical manufacturing industry, and how you ensured compliance with EU GMP Annex.
✨Demonstrate Your Training Skills
Since the role involves training operators, share examples of how you've successfully developed and implemented training programs in the past. Discuss your approach to ensuring that all team members understand aseptic behavior and hygiene practices.
✨Emphasize Your Problem-Solving Abilities
Consultys values transparency and collaboration. Be ready to talk about how you've worked with cross-functional teams to address gaps in processes or compliance issues, particularly in relation to Annex 1 remediation.
✨Prepare for Language Proficiency Questions
Fluency in both English and German is crucial for this position. Practice discussing your technical knowledge in both languages, as you may be asked to switch between them during the interview.
