75%:\t. Provide validation consulting services and project management for proprietary software products in a customer-facing capacity throughout the product deployment lifecycle.\t. Collaborate with customers during the presale stage to understand and clarify their requirements.\t. Translate customer requirements into validation deliverables.\t. Conduct gap analysis, formulate validation plans, and manage customer expectations.\t. Produce high-quality validation documentation ... more details
job summary: The Professional Services Team is enlarging its workforce to offer a heightened range of Computer Systems Validation (CSV) services and solutions to meet the escalating demands of our customers. As a pivotal member of the team, the LIMS CSV Specialist assumes responsibility for delivering CSV services. This may involve offering advisory consulting to clients on CSV, generating validation documentation and solutions that comply with pertinent
[
"
This position entails developing solutions to address continually evolving regulatory guidelines. The ideal candidate is expected to maintain current knowledge academically, professionally, and technically, and commit to ongoing development as an integral aspect of the role.
Responsibilities:
75%:
\t
Provide validation consulting services and project management for proprietary software products in a customer-facing capacity throughout the product deployment lifecycle.\t
Collaborate with customers during the presale stage to understand and clarify their requirements.\t
Translate customer requirements into validation deliverables.\t
Conduct gap analysis, formulate validation plans, and manage customer expectations.\t
Produce high-quality validation documentation and execute test scripts as necessary.\t
Offer expert validation consultancy to guide customers through the validation process.\t
Lead cross-functional teams in developing validation deliverables.\t
Analyze testing results and determine their acceptability.\t
Review, edit, and approve validation documentation.\t
Coordinate the completion and approval of all validation deliverables.\t
This role may involve up to 15% travel.
15%:
\t
Engage in pre-sales and marketing activities, including discussions with sales, PSO, and/or customers.\t
Identify opportunities for selling validation consulting services.\t
Collaborate with sales to develop proposals for validation services delivery, including cost and effort estimation and scope definition.\t
Work with employees and external regulatory bodies on the overall compliance strategy, which may include interacting with various departments to advise, promote, and develop professional validation services internally.\t
Stay updated on regulatory compliance organizations' developments to advise both internal and external customers on changing trends and requirements.\t
Provide support to the internal QA team if needed, including reviewing and revising system validation-related Standard Operating Procedures and Work Instructions.\t
Deliver training and mentoring in computer systems validation to relevant personnel.\t
Initiate and enforce necessary system corrections and improvements via system change controls and mitigation plans.\t
Report to management on issues such as non-conforming product and conflicting priorities.
Desired Competencies:
\t
Demonstrates a proactive attitude and represents the organization professionally.\t
Works well under supervision and seeks support for continuous learning.\t
Self-motivated with strong organizational and time management skills.\t
Capable of identifying and leading customer inquiries to the sales team.\t
Committed to continuous development of product knowledge.\t
Excellent communicator with a strong customer focus and relationship-building skills.
Job Qualifications:
\t
Proven experience as a CSV specialist in a consulting organization.\t
In-depth knowledge of validation deliverables at each stage of the computer system lifecycle.\t
Familiarity with industry standards and regulatory guidelines such as 21 CFR Part 11, Annex 11, Annex 15, GxP, ISO/IEC/IEEE.\t
Experience with generating and reviewing validation deliverables for various types of software.\t
Familiarity with change control processes, CAPA, and Quality Systems.\t
strong organization, time management, critical thinking, and problem-solving skills.\t
Excellent written and verbal communication skills.\t
Ability to work in cross-functional teams and build consensus.\t
Some project management skills required.\t
Proficiency in Microsoft Office Suite, particularly Excel, Word, and Project.
Job Abstracts is an independent Job Search Engine. Job Abstracts is not an agent or representative and is not endorsed, sponsored or affiliated with any employer. Job Abstracts uses proprietary technology to keep the availability and accuracy of its job listings and their details. All trademarks, service marks, logos, domain names, and job descriptions are the property of their respective holder. Job Abstracts does not have its members apply for a job on the jobabstracts.com website. Additionally, Job Abstracts may provide a list of third-party job listings that may not be affiliated with any employer. Please make sure you understand and agree to the website's Terms & Conditions and Privacy Policies you are applying on as they may differ from ours and are not in our control.
We would like to take a second to Welcome You to Job Abstracts, the nation’s largest Pure Job Board. With over 3.1 million job listings from 15,000+ Companies & Organizations, we help job searchers find careers that match their interests. As an anonymous user, you have probably discovered how easy our system is to use. However, you have just scratched the surface of what we can offer.
We encourage you to Register so you can use our most powerful features: searching with multiple terms, setting up multiple locations, establishing favorite companies, and accessing your search history. If you find a job you like, you can apply directly for it, and then, keep notes on it. We will also keep a lookout for jobs that match your search terms and email you when we find something you may like.
You can register for free and the system is free to use. If you like our system so far, click on Register and unlock the power required by serious job searchers.
Any time you conduct a search, the system shows you job matches, ranked by their Relevance Score (RS).
The score is calculated by a proprietary algorithm that uses Intelligent Machine Learning.
The Relevance Score tells you how well the job opportunity matches your search term or terms.
When not logged in, the system is limited to one search term. Scores for single term matches are usually lower.
When you register, log in, and set up multiple terms prioritized by importance, the jobs found for you will receive a much higher Relevance Score.