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 Setting:

- 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

📌 Validation Analyst (Bengaluru)
🏢 Thermo Fisher Scientific
📍 Bengaluru