projectSuccessfully occupied
Rate
8 000 € - 12 000 €
/
month
Form of cooperation
Part-time
Sector
Information Technology
Location
100% Remote
The reward is calculated upon delivery of 20 MD per month (1MD=8h)
Project duration
4 months
Period of cooperation
05.10.2026
- 31.01.2027
Start date
ASAP
Project duration
4 months
Period of cooperation
05.10.2026
- 31.01.2027
Start date
ASAP
Languages
-
Slovak or Czech
-
native
Project description
- ensuring SAP systems and processes comply with GxP, GMP, and internal quality procedures
- support for SAP implementations, upgrades, rollouts, validation, and application support
- preparation and maintenance of validation documentation, especially URS, FS, DS, IQ, OQ, and PQ
- creation of risk assessments and traceability matrices
- support for CSV activities in accordance with GAMP 5 and FDA/EU regulatory requirements
- collaboration with Quality Assurance, business, and IT teams during validation activities and audits/inspections
- performing impact assessments for system changes, deviations, CAPA, and change controls
- coordination and support of functional, regression, and User Acceptance Testing
- support of SAP modules QM, MM, PP, WM, EWM, SD, and related integrations
- ensuring data integrity in accordance with ALCOA+ principles
- preparation and updating of SOPs and training documentation
- providing support to end-users
- support for audits and preparation of relevant documentation
- collaboration on continuous improvement activities in a regulated SAP environment
- collaboration with local and international teams
- collaboration takes place in a 100% REMOTE and 50% part-time mode
Project requirements
- min. 3 years of project experience with SAP consulting in a pharmaceutical, biotech, or life sciences environment
- practical experience with SAP systems in a regulated environment
- ability to collaborate with Quality Assurance, business, and IT teams
- good analytical and communication skills
- stakeholder management experience
- experience with:
- SAP in a regulated environment
- GxP and GMP requirements
- GAMP 5
- Computerized System Validation (CSV)
- FDA 21 CFR Part 11
- EU Annex 11
- validation lifecycle
- URS, FS, DS, IQ, OQ, PQ documentation
- risk assessments and traceability matrices
- change controls, deviations, and CAPA
- audits and regulatory inspections
- functional, regression, and User Acceptance Testing
- data integrity and ALCOA+
- advantageous experience with:
- SAP S/4HANA implementations or migrations
- SAP QM, MM, PP, WM, EWM, or SD
- SAP integrations
- data integrity in a regulated environment
- cybersecurity in regulated systems
- international or multicultural teams
- knowledge of English (written and spoken) at a communicative level (min. C1)
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project?
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an IT specialist
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this project? Recommend him
and get a reward 1 000 €!
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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 1 000 €!
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