projectSuccessfully occupied
Rate
8 500 € - 10 500 €
/
month
The reward is calculated upon delivery of 20 MD per month (1MD=8h)
Form of cooperation
Freelance:
Full-time
Sector
Healthcare and Pharmacy
Location
100% Remote
Project duration
6 months with the possibility of extension
Period of cooperation
01.12.2026
- 31.05.2027
Start date
ASAP
Project duration
6 months with the possibility of extension
Period of cooperation
01.12.2026
- 31.05.2027
Start date
ASAP
Languages
-
English
-
active, B2/C1/C2
Project description
- ensuring compliance of development, validation, and operation of a cloud SaaS application with the regulatory requirements of the pharmaceutical industry (GxP)
- assessment of existing software development, testing, deployment, and operation processes from the perspective of GxP and GAMP 5 methodology
- defining, implementing, and continuously improving software validation strategy (CSV – Computerized System Validation)
- ensuring compliance of Agile and DevOps processes with pharmaceutical regulatory requirements
- identifying gaps in existing processes and proposing corrective actions to ensure GxP compliance
- preparation and review of validation documentation, including validation plans, risk assessments, requirements, test plans, test results, and validation reports
- setting up and controlling processes for change management, configurations, access rights, data integrity, and documentation of performed activities
- defining and updating standard operating procedures (SOPs), internal guidelines, control mechanisms, and responsibilities
- support for validation of SaaS solutions, related cloud infrastructure, and customer implementations
- preparation and support of internal, customer, and regulatory audits, including resolving identified deficiencies
- collaboration with development, DevOps, QA, operations, and pharmaceutical Quality/Validation teams
- providing expert advice and methodological guidance to technical teams in implementing GxP requirements
- possible REMOTE cooperation with the willingness to travel 1-2 times per quarter to Germany or Austria with reimbursement of travel costs
Project requirements
- minimum 5 years of experience in managing software development projects / teams in a pharmaceutical company and/or experience directly as a GxP consultant / GAMP 5 consultant
- essential practical experience with the implementation of GxP and GAMP 5, including their application in software development and validation
- demonstrable experience with CSV (Computerized System Validation) and software application validation
- good knowledge of SDLC (Software Development Life Cycle), i.e. requirements analysis, design, development, testing, deployment, change management, and operation
- fluent English spoken and written
- combination of experience from the pharmaceutical industry and the technical environment of software development
- experience with:
- SaaS/cloud applications, their life cycle, and the division of responsibilities between the provider and the pharmaceutical customer
- preparation and review of GxP validation documentation (Validation Plans, Risk Assessments, Requirements, Traceability Matrices, Test Plans/Reports, Validation Summary Reports)
- knowledge of pharmaceutical quality management systems, data integrity principles, and auditability requirements
- ability to transform regulatory requirements into specific technical and process measures
- excellent communication skills and experience in collaboration across IT, development, operations, and Quality/Validation teams
- advantageous experience with:
- managing pharmaceutical CSV/CSA validation activities
- Agile development, CI/CD, and DevOps in a regulated environment
- cloud infrastructure, SaaS operation, and regulated IT Service Management
- pharmaceutical audits, regulatory inspections, and corrective actions
- advantageous knowledge of:
- validation of GAMP 4 and 5 software categories (configured and custom-developed applications)
- EU GMP Annex 11 and FDA 21 CFR Part 11 regulatory standards
- German language
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Are you interested in this project?
Recommend an IT specialist
Do you know anyone who could use this project? Recommend him and get a reward 800 €!
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