Senior QA Specialist Validation
Vor 7 Tagen
About the Role
We are seeking a dedicated QA CSV Manager to join our Global Quality Unit. As a key member of our team, you will be responsible for ensuring computerized systems are appropriately validated according to Bachem internal standards.
Key Accountabilities- Validation and Approval of CSV Documents
- 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 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
- 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
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