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QA CSV Manager (f/m/d) 80-100%

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.

To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our new Global Quality Unit, we are looking for a dedicated QA CSV Manager (f/m/d) 80-100% in a newly created position.

 

Your tasks

  • Ensure computerized systems are appropriately validated according to Bachem internal standards
  • Review and approve CSV documents (e.g. validation plan/report, URS, FS, risk assessments, test protocols and test reports)
  • Guide and support teams implementing new projects to define and implement the appropriate way of CSV
  • Join future IT-related projects as QA representative
  • Oversee and support the life-cycle management of validated software systems incl. change management, periodic review, and system retirement
  • Provide training on CSV policies, SOPs, to internal stakeholders e.g. project team members, system owners
  • Participate in customer audits and authority inspections as CSV subject matter expert
  • Support the re-/evaluation of suppliers for software solutions
  • Maintain a close liaison with internal stakeholders e.g. Global IT, OT, MSAT, Quality Control

 

Your profile

  • Bachelor’s degree or equivalent qualification in information technologies, life sciences (chemistry, engineering) or similar
  • At least 3 years practical experience in computerized system validation in cGMP regulated environments in Quality Management departments, IT departments, or equivalent Consultant positions
  • Knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standards
  • Detail oriented with the ability to troubleshoot and resolve problems.
  • Hands-on when required
  • Ability to effectively work in a fast-paced, deadline driven work environment
  • Ability to work independently and manage one’s time
  • Ability to communicate in a proactive and solution-focused manner
  • Experience in working in cross-functional teams
  • Fluency in English (spoken and written), German also preferred

 

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!

 

Please note: unsolicited resumes from recruitment agencies will not be considered.

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