Switzerland Job Openings
Altogen
QA Specialist
Basel
FULL TIME
November 20, 2024
ALTOGEN SWITZERLAND is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices.
With several years of experience, technical expertise, and project coordination, we support our partners throughout all areas of the product life cycles. Since December 2023 the company has been part of the EFOR Group.
We surround ourselves with junior to expert consultants with strong development potential, whom we support in their professional goals.
Learn more about us on our webpage: www.altogen.ch
To strengthen our team in Switzerland, we are looking for a QA Specialist (m/f/x).
ABOUT THE JOB:
- Verification of the company compliance with ISO/c GMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing;
- Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1;
- Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support);
- 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;
- Additionally, you 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.
- You have 3-5 years of experience in Direct QA commercial drug substance/drug product or an equivalent amount of aseptic processing and cell therapy manufacturing experience;
- You know the GMP compliance and Part 11 compliance;
- You are experienced with oversight of aseptic processing and the associated international aseptic processing regulations;
- On top, you have excellent written and oral communication to include accurate and legible documentation skills;
- You have proven your ability to interface and communicate directly with clients when required;
- You are fluent in English (spoken and written) and ideally you understand and speak some German as well.
WHAT WE OFFER:
- A permanent contract and innovative projects;
- An attractive remuneration policy;
- Personalised management and continuous learning to develop your career;
- Great team spirt and an integration within the group.
Job Type: 100%
Schedule:
- Monday to Friday
- Overtime pay
- Vacation money
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