projectSuccessfully occupied
Rate
120 000 CZK - 160 000 CZK
/
month
Form of cooperation
Full-time
Sector
Information Technology
Location
100% Remote
The reward is calculated upon delivery of 20 MD per month (1MD=8h)
Project duration
4 months with the possibility of extension
Period of cooperation
01.09.2026
- 31.12.2026
Start date
01.09.2026
Project duration
4 months with the possibility of extension
Period of cooperation
01.09.2026
- 31.12.2026
Start date
01.09.2026
Languages
-
English
-
active, B2/C1/C2
Project description
- ensuring continuity of CSV compliance support for Capital Projects and strategic projects in a regulated pharmaceutical environment
- temporarily taking over compliance oversight during maternity leave to maintain the smooth progress of projects and validation activities
- creation, review, and approval of validation lifecycle deliverables in accordance with internal SOPs and regulatory requirements
- providing compliance guidance to project teams in the areas of SDLC, CSA, qualification, and risk-based validation
- creation and review of QAPs, risk assessments, requirements, testing documentation, and summary reports
- support for change controls, deviation processes, and compliance-related risk assessments
- timely identification, communication, and tracking of compliance risks and issues
- management of compliance trackers, metrics, and project reporting
- participation in project governance, compliance reviews, and other project meetings
- collaboration with Quality, Engineering, Automation, and Project Delivery teams
- support for the implementation of SOPs and other compliance initiatives
- collaboration from September 1, 2026, to December 31, 2026, with an expected extension to April 2027
- full remote collaboration with onsite presence in Prague approximately once a month
Project requirements
- extensive experience with:
- a minimum of 3 years of experience in the areas of Computerised System Validation (CSV), Computer Software Assurance (CSA), Automation Compliance, and Quality Systems
- compliance and validation in a regulated pharmaceutical or biotechnology environment
- Shopfloor Systems
- experience with:
- supporting Capital Projects and GMP computerized systems
- stakeholder management and communication across project teams
- independent work on multiple projects and across multiple locations
- advanced knowledge of:
- GAMP 5
- FDA 21 CFR Part 11
- EU GMP Annex 11
- risk-based validation and CSA principles
- Software Development Lifecycle
- knowledge of:
- Change Management and Deviation processes
- higher education in engineering, science, computer systems, or a related field
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