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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.

At Bachem, to drive our continuous organic growth, we are constantly looking for highly qualified professionals.To strengthen our new Global Quality Unit ensuring the validation of the GMP computerized IT systems used globally by Bachem sites (e.g. EDMS, ERP, LIMS, Validation & Qualification Execution System,  etc.), we are looking for a dedicated QA CSV Manager (f/m/d) 80-100%.

 

As QA CSV Manager you will ensure that the computerized IT systems in your portfolio are appropriately validated and remained in a validated state according to Bachem procedures.

 

Your tasks

  • Review and approve CSV documents of GMP computerized IT systems (e.g. validation plan/report, URS, FS, risk assessments, test protocols, test reports, etc.)
  • Join IT-related projects as CSV QA representative
  • Guide and support teams implementing new GMP computerized IT systems to define the appropriate validation strategies and deliver the corresponding CSV documents according to Bachem standards
  • Oversee and support the life-cycle management of validated GMP computerized IT systems incl. system upgrade, change management, periodic review, and system retirement
  • Provide training on Bachem CSV policies, SOPs, to internal stakeholders e.g. project team members, system owners, etc.
  • Participate in customer audits and authority inspections as CSV subject matter expert when needed
  • Support evaluation/re-evaluation of GMP computerized IT system suppliers
  • Maintain a close liaison with internal stakeholders e.g. Global IT, System Owners, Process Owners, etc.

 

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 IT system validation (CSV) 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 partial working time in 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? Are you interested? Then we look forward to receiving your complete application form via our application portal.

Learn more about the Bachem Group and be inspired by our working environment at our location in Bubendorf!

 

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

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