PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.
Currently we are looking for professionals to join our Global IT Team in Sofia as Validation Analyst
Purpose of the role:
The Validation Analyst will provide business/system support of software systems instrumentation. He/she will collaborate with various departments and the client to initiate and complete Performance Qualification (PQ) validation activities. Additional tasks would be to facilitate the validation process as well as implementation of system upgrades, including duties of guiding, testing, supporting the introduction, and ongoing support of software systems. The Validation Analyst will also participate as a member of the Project teams where needed and will help to provide direction on future enhancements to the system.
-Validation Support for new releases and modifications to applications throughout the Software Development Life Cycle
-Preparation of Validation Plans, Test Cases and Validation Summary Reports and executes Test Cases.
-Identification of user requirements and system design and assist in the preparation and review of system documentation such as requirements specifications and design specifications for software systems and/or instrumentation.
-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
-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
So if you have a client focused approach, detail orientation, and strong analytical and problem solving skills, apply with us now!
Please submit your CV in English.
This is an ongoing search. Suitable candidates will be contacted accordingly.