Assoc Validation Analyst

Work Schedule

Environmental Conditions

Job Description

The Associate Validation Analyst is responsible for providing basic business/system support for software systems and validated systems. Collaborate with various departments and clients to initiate and complete performance qualification (PQ) validation activities. Facilitate the validation process, system upgrades, and ongoing support of software systems.

Essential Functions:  

• Participates as a member of project teams where needed, contribute to system enhancements, review change requests, and ensure effective communication and testing accuracy.
• Provide validation support for new releases and modifications to applications throughout the software development life cycle.
• Prepares validation plans, Test Cases and validation summary reports and reviews test cases.
• Assists in reviewing and approving change controls for validated systems per SOP, ensuring test scripts meet functional requirements and business expectations. Review Performance Qualification (PQ) and Change Control documentation with leadership.
• Author PQ test cases (Test Planning and Test case creation).
• Writes and Executes Test Scripts accurately to produce evidence that the computer system consistently performs its intended functions accurately and reliably. Assists with creating, updating, and managing data within the testing environment, sufficient to accurately test software functionality.
• Provide ongoing business support to users during implementation and continued use of validated platforms, ensuring appropriate training, support, and maintenance is provided.
• Participate in Periodic Reviews to ensure Master Validation Plan remains up to date.

Job Complexity:

• Work on problems of limited scope, following standard practices and procedures to analyse situations or data.

Job Knowledge:

• Learn and apply professional concepts, company policies, and procedures to resolve routine issues.

Supervision Received:

• Receives close supervision and detailed instructions while developing the ability to work more independently.

Business Relationships:

• Primarily interact with immediate supervisor and department personnel. Build stable internal working relationships.

Qualifications

Education and Experience:  

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.  
• Demonstrated skill (1-2 years) in delivering the proficiencies needed to excel in the role. A combination of education, training, and directly related experience may be considered.

Knowledge, Skills and Abilities:

• Minimum 1 year of Computer System Validation (CSV) experience. – Must have
• Communication Skills: Candidate must be well spoken and possess strong oral and written communication skills. – Must have
• Customer-focused approach with strong interpersonal skills. – Must have
• Pharma industry experience or validation/testing experience in a regulatory environment is preferred.
• Strong attention to detail and problem-solving skills.
• Ability to adapt to changing priorities.
• Competency with Microsoft Office Suite (Word, Excel, PowerPoint).
• Positive attitude, passion, and ability to work well with others.
• Must be willing to work from 1 PM IST to 10 PM IST [3:30 PM PST to 12:30 AM PST] in Hybrid work mode.

Management Role:

• No management responsibility.

Working Conditions and Environment:

• Office environment with exposure to electrical office equipment.
• Occasional travel to site locations, both domestic and international.

Physical Requirements:

• Frequently stationary for 6-8 hours per day.
• Repetitive hand movements with the ability to make fast, simple, repeated movements.
• Frequent mobility required.
• Occasional crouching, stooping, bending, and twisting.
• Light to moderate lifting (15-20 lbs).
• Ability to use various computer software.
• Ability to communicate and understand information optimally.
• Frequent interaction with others to acquire or relate information.
• Work independently with minimal mentorship, planning work schedules to meet goals.
• Perform variable tasks under stress and multitask.
• Regular and consistent attendance.