Validation Analyst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Qualifications: 

Minimum Required Education and Experience:

• Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities.
• Fundamental training, knowledge and experience with systems and software validation processes.
• 2 years experience with systems or programming tools in use at PPD or within the CRO/Pharmaceutical industry.

Required Knowledge, Skills and Abilities:

• Client focused approach with strong interpersonal skills.
• Strong oral and written communication skills and ability to teach others.
• Strong attention to detail and problem solving skills.
• Competent with MS Word, MS Excel, MS PowerPoint, MS Project.
• Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others.
• Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
• Good understanding of clinical trials operational processes and terminology.
• Good understanding of software development life cycle (SDLC).
• Proven ability to learn new computer software with minimum of instruction.
• Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced.
• Ability to attain, maintain and apply a working knowledge of GCPs, applicable SOPs/WPDs, and Process Maps.
• Ability to review and critique SDLC documentation including Requirements, Functional Design, System Design, and Test Plans.
• Ability to assess the cause of test failures.

Working Conditions and Environment: 

• Work is performed in an office environment with exposure to electrical office equipment.  

• Occasional drives to site locations with occasional travel both domestic and international. 

Physical Requirements: 

• Frequently stationary for 6-8 hours per day.   

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.    

• Frequent mobility required.  

• Occasional crouching, stooping, bending and twisting of upper body and neck.      

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.  

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf. 

• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.  

• Frequently interacts with others to obtain or relate information to diverse groups.    

• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals.  Requires multiple periods of intense concentration.  

• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.  Ability to perform under stress.  Ability to multitask.    

• Regular and consistent attendance. 

Working Hours: 

India : 1:00 PM – 10:00 PM IST

Philippines : 3:30 PM - 12:30 AM PHT