Job Description:
To drive our continuous organic growth, we are constantly looking for highly qualified professionals to strengthen our new Global Quality Unit.
Responsibilities:
* 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
* Participate in 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 and 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
* Pension fund contributions paid by employer
* Access to benefits platform with many discounts at external partners
* Fresh, healthy, and varied food in staff restaurant
* A wide range of free sports activities on company campus