CSV Analyst

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Job Function:

Quality

Job Sub Function:

Business Process Quality

Job Category:

Professional

All Job Posting Locations:

Bogotá Distrito Capital Colombia

Job Description:

DePuy Synthes is recruiting for a CSV Analyst located in Bogota Colombia.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals. Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Job Overview

The CSV Analyst Quality Systems supports Computer System Validation (CSV) activities to ensure that qualityrelated computerized systemscomply withregulatory requirements quality system standards and internal policies. This role plays a key part inmaintainingdata integrity system compliance and audit readiness by supportingvalidationlifecycle activities across Quality Systems. The position partners closely with Quality IT and business stakeholders to enable compliant and reliable system operation.

Key Responsibilities

• Support computer system validation activities for qualityrelated systemsin accordance withregulatory and internal requirements.

• Executevalidationlifecycle activities including planning risk assessment testing documentation and maintenance.

• Support development and maintenance of validation documentation such as protocols reports and traceability matrices.

• Partner with Quality Systems IT and business teams to ensure compliant system implementation and change management.

• Support data integrity assessments and ensure adherence to data governance principles.

• Assistwith audit andinspectionreadiness related to computerized systems and validation activities.

• Monitorvalidationstatus issues and risks and support corrective and preventive actions.

• Contribute to continuous improvement initiatives to strengthen CSV processes and efficiency.

Qualifications

Education:

• Bachelors degree in Computer Science Engineering Information Systems Life Sciences ora relateddiscipline (required).

• Advanced degree in a technical or qualityrelated field (preferred).

Experience and Skills:

Required:

• Typically2-4years of experience supporting computer system validation or quality systems in a regulated industry.

• Working knowledge of CSV principlesvalidationlifecycle and regulatory expectations.

• Experience supporting audits inspections or compliance assessments involving computerized systems.

• Strong documentation skills with attention to detail and data integrity.

• Ability to collaborate effectively with crossfunctional technical and quality teams.

Preferred:

• Experience in medical devices pharmaceuticals or other highly regulated industries.

• Familiarity withGxPrequirements and data integrity principles.

• Experience working in a global or matrixed organization.

• Exposure to electronic quality management systems (eQMS).

• CSV or qualityrelated certifications.

Other:

• Language: Spanish and English.

• Travel: Limited; occasional domestic travel.

• Certifications: CSV or Quality certifications preferred but not.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers

Required Skills:

Preferred Skills:

Business Behavior Business Process Management (BPM) Business Requirements Analysis Coaching Compliance Management Cross-Functional Collaboration Data Reporting Detail-Oriented Execution Focus Goal Attainment Leverages Information Problem Solving Process Optimization Process Oriented Quality Control (QC) Quality Management Systems (QMS) Quality Standards Technical Writing

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1