Business Analyst – ECM / Vigilance (GxP & Testing)

Hiring: Business Analyst – ECM / Complaints Management (GxP & Testing)

About the role

Seeking an experienced Business Analyst/Tester with background in Enterprise Complaints Management (ECM), Vigilance, or Product/Manufacturing Incident systems within Life Sciences / Pharma / Medical Device environments.

Responsibilities

• Develop and execute test cases for ECM, Vigilance, and Product/Manufacturing Incident systems
• Conduct System Integration Testing (SIT) and User Acceptance Testing (UAT)
• Collaborate with cross-functional teams to gather and document requirements
• Create Business Requirement Documents (BRD) and Functional Requirement Documents (FRD)
• Support the development and maintenance of Regulatory Templates (RTM)
• Ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other relevant regulations

Requirements

• Minimum 5 years of experience in ECM, Vigilance, or Product/Manufacturing Incident systems within Life Sciences / Pharma / Medical Device environments
• Strong experience in testing, including test case creation and SIT/UAT execution
• Proven knowledge of GxP, CSV, and regulated environments
• Experience with Product or Manufacturing Incident data management
• Proficiency in Business Analysis, including requirements gathering and documentation

Nice to have

• Experience with Quality/Manufacturing systems (CAPA, deviations, complaints)
• Pharma/Medical Device domain expertise

Benefits

Mandatory 3 days onsite per week

Pay

Competitive salary based on experience

Schedule

Immediate start – long-term contract through 2026

Qualifications

• BS/MS in Life Sciences, Engineering, or related field
• Valid driver’s license required