Select how often (in days) to receive an alert: 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 At Bachem, to drive our continuous organic growth, we are constantly looking for highly qualified professionals 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 Review and approve CSV documents of GMP computerized IT systems (e.g. validation plan/report, URS, FS, risk assessments, test protocols, test reports, etc.) 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 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
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