CSV Specialist
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Job Location:
Weesp - Netherlands
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
CSV Specialist
Are you passionate about Computer System Validation (CSV) and ensuring data integrity in a regulated environment Do you thrive on influencing strategy coaching teams and driving compliance excellence If so we want you on our team!
Abbott Established Pharmaceuticals
We are committed to bringing the benefits of our trusted medicines to more people in the worlds fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology womens health cardiometabolic pain management/central nervous system and respiratory.
About the role
As a CSV Specialist you will play a critical role in safeguarding GMP-related computer systems. Youll act as a trusted advisor and subject matter expert guiding policy decisions leading validation projects within the quality control department and supporting audits with confidence.
What Youll Do
- Advise & Influence: Shape policy proposals and implementation strategies for CSV and data integrity in GMP environments.
- Validate & Maintain: Ensure the validated state if laboratory software by managing change control and updating documentation in compliance with GxP and cybersecurity requirements.
- Drive Compliance: Prepare and execute validation plans protocols and reports for computer systems.
- Lead Audits: Represent CSV expertise during audits and project reviews.
- Continuous Improvement: Conduct periodic system reviews and recommend re-validation when needed.
What Were Looking For
- Bachelors degree in STEM.
- 2-3 years of relevant experience in Computer System Validation.
- 2-3 years of experience in a laboratory environment is strongly preferred.
- Strong knowledge of GAMP5 and regulatory guidelines (EU GMP Volume 4 Annex).
- Analytical mindset with strategic influence and stakeholder management skills.
- A proactive team player who drives results and anticipates challenges.
- Fluent in Dutch and English verbally and written.
Why Join Us
- Be part of a mission-driven organization committed to quality and compliance.
- Work in a collaborative environment where your expertise makes an impact.
- Opportunities for professional growth and continuous learning.
Ready to make a difference
Apply now and help us shape the future of compliance! All applications needs to include a CV and cover letter.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
Netherlands > Weesp : WWA A-C-D
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
