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Manager Computerized System Validation
vor 5 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 Computerized System Validation - CSV (f/m/d) 80-100%
Your tasks
- Ensure computerized systems are appropriately validated according to Bachem internal standards.
- Ensure availability of a global state-of-the-art CSV framework (policies, SOPs, working instructions).
- Guide and support project teams to define and implement the appropriate way of CSV.
- Review and approve CSV documents (e.g. validation plan/report, URS, FS, risk assessments, test protocols and test reports).
- Provide training on CSV policies, SOPs, industry regulations and trends to internal stakeholders e.g. project team members, system owner.
- Participate in customer audits and authority inspections as CSV subject matter expert.
- Support the re-/evaluation of suppliers for software solutions.
- Oversee and support the life-cycle management of validated software systems incl. change management, periodic review, and system retirement.
- Maintain a close liaison with internal stakeholders e.g. Global IT, OT, MSAT, Quality Control.
Your profile
- Bachelor Degree or equivalent qualification in information technologies, life sciences (chemistry, engineering) or similar.
- At least 5 years’ experience in computerized system validation in cGMP regulated environments in Quality Management departments, IT departments, or equivalent Consultant positions
- Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards.
- Experience in implementation and/or maintenance of computer system life cycle management standards.
- 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 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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