Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Validation Specialist for our client in Princeton, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- 6+ years experience needed
- Recent Data Integrity experience in a GxP environment
- Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
- Able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries.
- Experience in producing software documentation and business requirement documentation (minimum 3 yrs); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance.
- Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes
- Follow SOPs and industry best practices
- Conduct training on good documentation and good testing practices
- Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system
- Review validation deliverables for projects which are contracted to third party suppliers
- Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
- Assist in planning, implementing, and documenting user acceptance testing
- Review computerized systems validation documents such as:
- Requirements Specification
- Design Specification
- CSV Risk Assessment
- Test Plans
- Test Summary Reports
- Data Migration Plan
- Pre/Post Executed Test Scripts
- Traceability Matrix
- Release to Production Statements
- Direct and review testing
- Provide guidance on quality issues that affect the integrity of the data or the system
- Prepare validation summary and test summary reports
- Obtain and respond to QA review
- Participate in establishing standard quality and validation practices
- Independently assess compliance practices and recommend corrective actions
- Approve validated computer system related change requests
- Monitor regulatory and inspection trends and advise the business on suitable action
- Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
- Ability to create documents to an existing document standard.
- Working knowledge of Documentum.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying? Contact Joy Retanan at (646) 695-2949 or at http://www.linkedin.com/pub/joy-retanan/85/4ba/333 or send your resume to Joy.Retanan@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.