CSV Expert (Pharma)

Responsibilities

Project No.:

1085300

Project Title:

1085300 CSV Expert (Pharma)

Job Type:

Freelance

• Hands-on support in 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
• (Re)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 Analyses
• Test Documentations
• User Acceptance Tests (UAT)
• Traceability Matrices
• Validation and Completion Reports
• Not a classic consulting role, but rather driving the CSV process hands-on, especially regarding documentation, while ensuring GMP compliance; the main task is documentation

Requirements

Additional Information:

SOLCOM is one of the leading technology service providers in the areas of software development, IT, and engineering. For over 20 years, we have been working as partners with globally operating top companies in all industries and are active worldwide wherever innovation is decisive.

• 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 analyses, 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 equivalent 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
• Documents/SOPs all in paper form in thick folders, independently navigate through documents, approach colleagues, search proactively
• Absolutely hands-on with a lot of initiative, open to routine work and delving deep into SOPs

Project details

Zell (Canton of Lucerne)

2026-11-30

1 year +

• Start: 2026-11-30
• Duration: 12 Monate
• Remote: onsite
• Location: Zell (Kanton Luzern), Deutschland, DE
• Languages: German