Senior Business Analyst

Role:Senior Business Analyst - Validation & QMS Expert

Experience Level: 4to 8 Years

Work location:Mumbai/ Bengaluru/ Trivandrum

Role & Responsibilities

• Deliver validation projects successfully across R&D, Clinical, Quality, Regulatory, Digital Transformation, Platform Implementation, and Automation within the GxP environment.
• Serve clients as a Life Sciences Subject Matter Expert, including Keep up with the latest developments in industry, competition, technology advancements and share through publications through various channels including customer advisory meetings, conferences, social media.
• Provide compliance guidance across IT, business leadership, and stakeholders, focusing on computerized system validation (CSV) in a GxP regulated environment.
• Lead and oversee the validation and qualification processes for GxP computerized systems and infrastructure, both on-premises and cloud-based, to ensure adherence to 21 CFR Part 11 compliance and other relevant regulations
• Write, review, and approve CSV lifecycle documents, including validation plans, GxP assessments, traceability, matrices, risk management plans, and validation summary reports.
• Evaluate new computerized systems or software for GxP impact and provide risk-based validation guidance.
• Demonstrate strong consulting and advisory skills, including analytical capabilities, ability to synthesize content, and translate it into sound recommendations and deliverables.
• Implement problem-solving procedures to enhance efficiency in resolving customer issues.
• Support team building activities through recruitment, motivation, and learning with a strong focus on people development.
• Coach junior consultants on core consulting skills and subjects with experience.
  

Must Have Skills

• 4- 8 years of experience in management consulting or relevant roles within the life sciences industry.
• Proven experience in IT compliance and validation within a GxP regulated environment, specifically with 21 CFR Part 11 compliance.
• Strong understanding of regulatory requirements (FDA, EMA, MHRA) and industry standards (ISO, IMDRF, PIC/s) in life sciences.
• Must have experience direct advising customers on in 3-5 below-mentioned areas:
• Patient journey mapping , Cross-platform integration and innovation, Clinical Data management, Digital and mobility solutions for Pharma, Digital and Web analytics, HCP Engagement strategy, Digital operating model.
• Analytical Problem-Solving: Decode complex business challenges and propose effective solutions.