Computer System Validation Specialist - CSV Specialist

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MidHybryda·WarszawaFull-time·Umowa o pracę

#462876·Dodano 6 dni temu·2

Źródło: justjoin.it

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Tech Stack / Keywords

AtlassianCSVProcess Engineeringpharmaceutical engineeringComputer scienceGXP

Podsumowanie oferty

You will plan and execute computer system validation (CSV) projects across areas including document management, IT infrastructure, pharmacovigilance, maintenance and application management. The role focuses on validation documentation, testing, data integrity and GxP-compliant systems.

Wymagania

Our requirements:

Degree in computer science, pharmaceutical engineering, process engineering or a similar field.
At least 2 years of practical experience validating computerized systems (CSV).
Proficiency with Atlassian tools.
Excellent teamwork, communication and problem-solving skills.
Written and spoken Polish and English at C1 level.
Strong team and performance orientation, and flexibility.
Assertiveness, reliability and the ability to work independently.
Ability to work autonomously in a dynamic, fast-paced environment.
Proficiency in validation methodologies and quality management systems.
Ability to execute risk assessments, validation planning, protocol development, testing and reporting.

Nice to have:

Understanding of GxP regulations.

Obowiązki

Key Responsibilities:

Oversee CSV projects in document management, IT infrastructure, pharmacovigilance, maintenance and application management.
Plan, manage and execute CSV projects.
Develop and implement validation documentation.
Plan and conduct tests, documenting them in accordance with GxP regulations.
Create, update and further develop work instructions (SOPs) and project-related documentation.
Ensure GxP-compliant operation of application systems.
Support adaptations and changes through change management in coordination with quality management.
Report directly to the CSV Lead at the company headquarters in Freiburg.
Create risk analyses and data maps, and implement the ALCOA principle to ensure data integrity.
Cooperate primarily with the company’s German branch and additionally with other company branches.
Manage system validation documentation and records in accordance with data integrity and compliance standards.
Participate in audits and inspections, and defend validation practices and documentation before regulatory authorities.

Benefity

Co-financing for Multisport/Medicover Sport.
Co-financing for Medicover/LuxMed.
Company Social Benefit Fund supporting social activities for employees and their families.
Quarterly bonuses.
Employee referral program with a bonus for referrals.
Internal and external training.
Company breakfasts and integration events.
English classes; advanced learners can also study German.
An extra day off for your birthday.
Comfortable workstations, laptops and the equipment needed for the role.

Karta sportowa

Opieka zdrowotna

Premie

Spotkania integracyjne

Kursy językowe

Płatny urlop

Inne informacje

Business travel to Germany is required.
Recruitment process: application screening and brief feedback; a short phone interview with an HR Specialist; a Teams meeting with HR and a Quality Assurance Manager or Global Quality Director, including a recruitment task; a second-stage meeting with the Global IT Director and CSV Team Leader; and a third-stage on-site meeting with the HR Manager and Department Manager to discuss employment details. Successful candidates begin with a probationary period.

Komtur Polska Sp. z o. o.

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