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Manager Group Quality System
vor 4 Monaten
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.
To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in the new Group Quality organization, we are looking for a dedicated Manager Group Quality System (f/m/d) 80-100%.
Your tasks
- System administration and higher-level system support for Bachem’s global eQMS system including upgrade/patch management, troubleshooting, communication with the vendor, etc.
- Ensure cGMP compliance of Bachem’s global eQMS system and imbedded processes e.g. document and training management, quality event and change management.
- Offer expert-level insights on eQMS processes, serving as a reference point for internal stakeholders.
- Implementation and documentation of new system configurations, system changes, data migrations, etc.
- Implementation and harmonization of cGMP eQMS processes across Bachem sites.
- Execution and documentation of system tests and system validation.
- Administration, creation and revision of global documents in Bachem’s global DMS.
- Lead and/or collaborate in digitalization projects as QA representative.
- Support of customer audits and authority inspections as SME for Bachem’s global eQMS system and imbedded processes.
Your profile
- Bachelor Degree or higher qualification in information technologies, life sciences (chemistry, engineering) or similar.
- At least 5 years’ experience in Quality System Management in cGMP regulated environments.
- Thorough knowledge of cGMP regulations related to computerized system validation including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards.
- Experience in the configuration of database supported software solutions e.g. DMS, QMS, LIMS, ERP.
- Experience in working in cross-functional teams.
- Ability to communicate in a proactive and solution-focused manner.
- Detail oriented with the ability to troubleshoot and resolve problems.
- Ability to effectively self-organize, multitask, and work in a fast-paced, deadline driven work environment.
- Ability to work independently and manage one’s time.
- Fluency in German and English (spoken and written)
Our offer
- A dynamic and rapidly growing working environment with internal development opportunities.
- Flexible working hours with the possibility of home office.
- Employee development through numerous internal and external training opportunities.
- As standard, Bachem AG pays 60% of the pension fund contributions.
- Access to the Swibeco benefits platform with many discounts at external partners.
- Fresh, healthy, and varied food in our staff restaurant.
- A wide range of free sports activities on the Bachem Campus.
Would you like to drive innovation together with us?
Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal.
Learn more about the Bachem Group and be inspired by our inspiring working environment at our location in Bubendorf
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