IT Business Analyst for eDMS/QMS
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SeniorFull-time
#324298·Dodano 21 dni temu·23
Źródło: nofluffjobs.comTech Stack / Keywords
Business AnalystGXPISOVaultQA
Firma i stanowisko
Galderma is a dermatology company present in approximately 90 countries, delivering a portfolio of premium brands and services in Injectable Aesthetics, Dermatological Skincare, and Therapeutic Dermatology. Founded in 1981, the company focuses on skin health and partners with healthcare professionals to meet consumer and patient needs.
Wymagania
- Significant experience as an IT Business Analyst working with eDMS and/or QMS in regulated industries (pharmaceutical, medical devices, cosmetics or similar)
- Strong understanding of GxP, ISO, and 21 CFR Part 11 requirements
- Proven experience in requirements gathering, process mapping, and system validation within validated environments
- Hands-on experience implementing, enhancing, or maintaining platforms such as OpenText, Veeva Vault, MasterControl, or TrackWise
- Experience managing vendors and cross-functional stakeholders (QA, IT, business users)
- Fluent English, written and spoken
Obowiązki
Business Analysis & Solution Design:
- Lead end-to-end requirements gathering for eDMS and QMS solutions
- Translate complex business needs into clear functional and technical specifications supporting document lifecycle management, quality control, and compliance
System Implementation, Validation & Compliance:
- Support implementation and optimisation of eDMS/QMS platforms
- Ensure compliance with GxP, ISO, 21 CFR Part 11, including validation activities (UAT, documentation, audit readiness)
Stakeholder Partnership & Governance:
- Act as primary liaison between IT, Quality, Regulatory, and business teams
- Facilitate workshops, drive alignment, and ensure solutions meet cross-functional requirements
Process Optimisation & Continuous Improvement:
- Analyse and map current document and quality processes
- Identify improvement opportunities to enhance efficiency, compliance, and data integrity
Data Migration, Integration & Vendor Management:
- Lead or support data migration initiatives and system integrations (ERP, LIMS, CRM)
- Contribute to vendor selection, solution evaluation, and ongoing partner collaboration
Training, Adoption & Support:
- Develop training materials and deliver key-user sessions
- Provide ongoing support to ensure strong system adoption and optimal performance
Project Delivery & Risk Management:
- Support IT project execution within scope, timeline, and budget
- Proactively identify and mitigate risks to ensure system stability and regulatory readiness
Oferta
- Competitive compensation package with bonus structure and extended benefits
- Hybrid work culture (3 days/week onsite in Krakow)
- Personalized career path through feedback loops
- Working in a diverse and inclusive organization
- Sport subscription
- Private healthcare
- Flat organizational structure
- International projects
- Hybrid Work Allowance
- Corrective glasses reimbursement
- Company products discount
- Short-term incentive (STI) Bonus
- Pension plan
- Free coffee, snacks, and beverages
- Playroom
- Mobile phone
- In-house trainings
- Modern office environment
- Startup atmosphere
Karta sportowa
Opieka zdrowotna
Elastyczne godziny
Bonusy
Telefon służbowy
Szkolenia wewnętrzne
Darmowe napoje
Darmowe przekąski
Galderma
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