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

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