Required skills
- Computerized System Validation
- GMP Annex 11
- 21 CFR Part 11
- PIC/S
- Data Integrity
- ALCOA+
- Periodic Reviews
- CAPA Management
- User Requirement Specifications
- System Requirement Specifications
- Functional Specifications
- Risk Assessment
Languages: German
Job description
Seeking a hands-on CSV Expert with at least 5 years of experience in the pharmaceutical industry to support CSV activities, validation, and documentation according to GMP Annex 11 and other regulations.
Project overview
Hands-on support for carrying out the CSV activities required by the VMP (Validation Master Plan) and review/validation of computerized systems according to the newly introduced CSV framework.
Periodic qualification and documentation (Periodic Reviews) of all computerized systems (production systems, software, devices with control or data processing) according to GMP Annex 11 and subsequent implementation of CAPA measures.
Creation, review, and revision of CSV documents, for example:
Validation Plans
User Requirement Specifications (URS)
System Requirement Specifications (SRS)
Functional Specifications (FS)
Risk Assessments
Test Documentation
User Acceptance Tests (UAT)
Traceability Matrices
Validation and Completion Reports
Not a classic consulting role, but hands-on driving the CSV process, especially regarding documentation, while ensuring GMP compliance; the main task is documentation.
Requirements
Min. 5 years of experience in CSV (Computerized System Validation) in the PHARMA environment, including many years of experience in creating/reviewing/approving CSV documents (SRS, FS, IQ, FT, UAT, risk assessments, traceability, etc.).
Very good regulatory knowledge in GMP, Annex 11 (SW validation; part of the EU-GMP guidelines), PIC/S, data integrity (ALCOA+), 21 CFR Part 11 (US counterpart to Annex 11).
Many years of experience in handling Periodic Reviews and CAPA measures.
General know-how in ensuring that computerized systems comply with regulations (according to PIC/S, Annex 11, 21 CFR Part 11) and are approved by Swissmedic/FDA.
Documentation is the main task.
Periodic Reviews in the context of Swissmedic inspections.
Dokus/SOPs all in paper form in thick folders, independently navigate through documents, approach colleagues, proactively search.
Absolutely hands-on with a lot of initiative, open to routine work and delving deep into SOPs.
Additional Information:
Project No.: 1085300
Job Type: On-site
Start Date: 11/30/2026
Project details
1 year +
- Start: 30.11.2026
- Duration: 1 Jahr +
- Location: DE
- Languages: German
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