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EDC Validation Associate invited in Parexel


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PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Post: EDC Validation Associate

Job Description:
- Deliver a positive, memorable and meaningful service which exceeds the expectations of both the internal and external customer.
- Participate in all validation efforts associated with any Study.
- Document thoroughly the steps of and perform Study Functional Test Cases.
- Document test results (via detailed problem descriptions and test reports).
- Communicate test plan status and help determine critical path decisions.
- Manage defects using automated defect tracker.
- Produce input to reports to communicate status on study functionality and quality.
- Design and implement automated test scripts from manual test, as needed.
- Work validation lead on validation initiatives.
- Input into project design and specification with respect to optimal ways to achieve validation of certain functionality.
- Development of test plan (essentially built from standard design/test elements using Visio Design Tool and design of testing for any additional coding), collation and review of programmer test evidence/results and approval of project to pass to project team UAT phase.

- Develop project-specific test cases and produce templates of Validation Test Results as re-useable library sets to adequately test assembled projects. Co-ordination of testing through project team and/or others as appropriate.
- Develop Validation Reports ready for approval by PM
- Ensure the company remains compliant with Regulatory Body requirements, specifically FDA 21 CFR, Part 11.
- Work with the Quality Assurance Department to ensure consistent approach to the description and implementation of validation processes within Operations
- Responsible for the delivery of personally assigned objectives to agreed standards and within agreed timescales.
- Responsible for the management and co-ordination of all client project validation documentation assigned to the team, ensuring it is fully validated in accordance with company, industry, and regulatory standards.
- Development and Implement appropriate standard operating procedures and associated documentation

Candidate Profile:
- Excellent verbal and written communication skills
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Knowledge in Validation or Quality Assurance.

Education- Bachelor's degree preferred (or equivalent work experience)

Language Skills- English

Minimum Work Experience
- Minimum 1 years experience in validation or quality assurance of technical applications
- Preferred 2 years of clinical trial experience

Additional Information:
Experience: 1-2
Location: Hyderabad
Education: B.Pharm,
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: pharmacovigilance
End Date: 17th May, 2012


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