**About Convatec**
Job Description Summary
We're looking for an **eCSV Senior Analyst** with a strong focus on **GxP** to join our team. This is a unique opportunity to oversee projects, ensure all applicable regulatory and compliance requirements are met, and confirm that systems are defendable during an inspection. If you are passionate about quality assurance and compliance and want to be part of a team that directly impacts the integrity of our systems, we want to hear from you.
**Main Responsibilities**:
- Assess new computerized systems or software to determine their **GxP impact**, and provide guidance on a risk-based validation approach.
- Review proposed changes to validated computer systems/qualified IT infrastructure and identify the necessary validation or qualification requirements.
- Ensure all changes are implemented and documented in a compliant manner.
- Perform periodic assessments to review and confirm the validated status of systems.
- Oversee **GxP-impacting projects** to ensure all applicable regulatory and compliance requirements are met.
- Establish and maintain the **Software Validation Master Plan (SVMP)** and archive validation documentation.
- Ensure necessary employee training on the software.
- Prepare and close all **CSV-related** deviations, discrepancies, and change control documents.
- Evaluate IT service and solution suppliers.




- Maintain up-to-date knowledge of evolving regulatory requirements and act as an information resource for teams.
**Key Requirements and Competencies**:
- Bachelor's degree in computer science, engineering, life science, or a related field.
- Experience in **computer systems validation**.
- Knowledge of and experience with industry regulations and guidelines, such as **GxP** and **21 CFR Part 11**.
- Experience in the pharmaceutical manufacturing or medical device industry.
- Experience with equipment/process validation lifecycle management.
- Proficiency in developing validation documentation.
- Fluency in English (verbal and written).
- Strong collaboration and communication skills with Project and Quality validation teams.
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**Equal opportunities**
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.
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📌 Ecsv Senior Compliance Advisor (Del Norte)
🏢 Convatec
📍 Del Norte