Senior Validation Consultant
Responsibilities :
- Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements.
- Prepare training materials and perform training and coaching for all team members.
- Perform validation of products and services and qualification of software / hardware (Clinical SaaS software (customer facing), SDLC tools and other operational enablement software that are internal)
- Manage a continuous improvement backlog for all processes enforced by the SDLC and CSV validation procedures.
- Ensure training gaps, process gaps, audit findings and quality incidents have corrective and preventive actions in place.
- Liaison with business, technical and other compliance stakeholders to ensure the SDLC procedures and associated templates work as intended to enforce compliance at all levels.
- Participate in remediating audit findings and quality incidents.
Requirements :
- Well versed with GxP validation protocols aligned to US FDA CFRs particularly CFR Part for electronic records and electronic signatures and EU guidelines including Annex .
- Hands on experience validating cloud applications including portals, websites, and mobile applications.
- Experience validating systems that are AI / Client products in itself or use AI / Client components.
- Strong focus on risk assessment and validation of parameters impacting patient safety, product quality and data integrity.
- Ability to perform regulatory interpretation as and when required and provide data and clarifications.
- Be able to develop metrics to assess validation throughput, record and follow up on non-conformances as well as CAPA from product requirement initiation to launch.
- Experience ensuring audit readiness and leading audits
- Experience in audit readiness for FedRAMP certification
Senior Validation Consultant
Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements. Perform validation of products and services and qualification of software/hardware (Clinical SaaS software (customer facing), SDLC tools and other operational...
Senior Validation Consultant
Develop SDLC and associated CSV validation procedures, templates, and job aids in alignment to regulations and other compliance requirements. Perform validation of products and services and qualification of software/hardware (Clinical SaaS software (customer facing), SDLC tools and other operational...
Data Analyst
N4 Solutions, LLC is seeking a Data Analyst to support our customer. Oversee the aggregation, assimilation, and curation of data into a coherent repository, maintaining the accuracy of the T2 database to facilitate various reporting requirements. Generate synthesized data reports to facilitate infor...
Revenue Systems Business Analyst
A company is looking for a Revenue Systems Business Analyst. ...
Engineer, Software Development & Engineering – SDET - 7682
Make your mark at Comcast -- a Fortune 30 global media and technology company.From the connectivity and platforms we provide, to the content and experiences we create, we reach hundreds of millions of customers, viewers, and guests worldwide.Become part of our award-winning technology team that turn...
Supply Chain & Logistics Executive Recruiter
We are HIRING Supply Chain & Logistics Executive Recruiters to support the greater Baltimore MD Market!!!. Our typical hiring profile has changed a little so we are focusing on recruiters with current/recent full-desk recruiting experience. The Executive Recruiter role is responsible for proactively...
Recruiter
CSP has been engaged by a private equity backed Fire Protection company to conduct a search for a Recruiter. The Recruiter is a very hands-on position and will research, develop, and implement effective recruiting strategies to attract a diverse pool of qualified and capable talent for the organizat...
Data Analyst Intern
Gathering data from various sources, including databases, spreadsheets, APIs, and other systems. Identifying and correcting errors, handling missing data, and preparing data for analysis by organizing, cleaning, and structuring it. Using statistical methods and data visualization techniques to inter...
Project Manager (Developer/ Reviewer)
Position: Project Manager (Developer/ Reviewer). Our client is seeking a Project Manager to assist D3 Access management in reviewing TIS to ensure the proposed development does not adversely impact operations and safety of the existing network. ...
Residential Service Plumber
WE KNOW HOW TO TAKE CARE OF AND VALUE OUR TEAM MEMBERS!.Just as we take excellent care of our customers, we strive also to create a healthy work/life balance with deep respect for the quality-of-life for all our technicians.With a laid-back environment and excellent leadership, we also value our tec...