4 Jobs in KING OF PRUSSIA, PA
Cynet Systems is Hiring a Validation Lead Near King of Prussia, PA
Pay Range $65hr - $70hr
Responsibilities:
- 7-10 years Experience in the Validating LIMS systems and SaaS systems Experienced in CSV activities in Lab related applications like LIMS, ELN, Lab Instruments and.
- Equipment systems and has a clear understanding of various Lab systems and processes Perform Quality and Compliance documentation review for GxP and non-GxP systems to ensure compliance with regulatory requirements.
- Working knowledge on end-to-end validation of GxP applications and is able to perform document/process Compliance Analysis of the documentation process.
- Adept with Agile and Waterfall methodology-based software development Compliance and has prior experience in Computer System Validation using Agile methodology Reviews.
- Requirement Specifications, Functional Specifications/ User Stories / Acceptance Criteria and ensures completeness of test script with traceability Ensures Risk. Assessment is completed for all the requirements and test cases are designed In reference to the risk levels identified for the requirements.
- Performs review of pre-executed test protocol which includes all the basic elements of a test script, completeness and appropriateness of the test case to the requirement Ensures pre-executed test protocol has the necessary test data requirements to run the tests.
- Reviews post-executed test protocols for the completeness, accuracy of the results and evidence and enables the team on the defect management process Able to author. Validation Plan and compile Validation Summary Report and generates RTM Performs Change Requests Implement and Close Change Request which includes to check for the application controls and associated documentation process for end to end Change Request process.
- Reviews and ensures that the Operational Procedure for the application is ready Ensures that the document deliverables are Attributable, Legible, Contemporaneous, Original and Accurate and if any e-Signatures are applied then they are applied as per the defined workflows Is able to handle Change. Requirement related implementation for small changes - responsible for.
- Implementation Plan, Impact Assessment, Test Plan/ Results, Defects and RTM Prior experience in using tools like ALM, DMS and JIRA.
- Coordination with Engineers and attending customer calls.
- Raising risks, issues and escalation to senior management and customers.
- To create all quality documents, collect metrics data and conduct Audits.
- To perform Value creation and KM activities.
- To create project plans and keep track of schedule for on time delivery as per the defined quality standards.
- To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents.
Job Summary
Contractor
IT Outsourcing & Consulting
$59k-79k (estimate)
04/18/2024
10/22/2024
cynetsystems.com
ARCOLA, VA
500 - 1,000
2010
ASHWANI MAYUR
$50M - $200M
IT Outsourcing & Consulting
Related Companies
The job skills required for Validation Lead include Analysis, Computer Systems, Test Plans, etc. Having related job skills and expertise will give you an advantage when applying to be a Validation Lead. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Validation Lead. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Validation Lead positions, which can be used as a reference in future career path planning. As a Validation Lead, it can be promoted into senior positions as a Validation Engineer II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Validation Lead. You can explore the career advancement for a Validation Lead below and select your interested title to get hiring information.
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