Solvias ยท 18 hours ago
Senior Specialist, Computerized Systems Validation (CSV)
Morrisville, NC
Full-time
Onsite
Senior Level
5+ years expSolvias is a global provider of chemistry, manufacturing, and control analytics to the life sciences industry. The Senior Specialist, Computerized Systems Validation (CSV) will support quality operations for Large Molecule & Advanced Therapy Medicinal Products testing services in a GMP laboratory environment, ensuring compliance with regulatory requirements and overseeing the validation of electronic systems.
CosmeticsManufacturingMedical DevicePharmaceutical
No H1B
Hiring Manager
Daejia C. Hood, MBA, NCCP, SPHR, SHRM-SCP
Responsibilities
Ensure work is executed in compliance with GMP regulatory requirements and SOPs, such as 21 CFR Part 11, Annex 11, ICH E6 R2, OECD Advisory Document 17, applicable Predicate Rules, etc
Interpret technical information with a focus on quality using industry-accepted risk-based approaches
Work across multiple quality processes within the QMS to support daily operations and ensure delivery of reliable data to clients
Provide timely and effective communication to impacted stakeholders across different functional areas
Contribute to continuous improvement of quality and business processes and represent a culture of quality at the site
Perform or support internal and external audits of electronic systems to verify that systems are validated and maintained in a validated state in accordance with Solvias standards and regulatory requirements
Provide compliance oversight for the validation and maintenance of electronic systems in accordance with Solvias computer system validation (CSV) procedures and regulatory requirements
Review and approve CSV deliverables such as Validation Plans, Functional Requirements, Test Scripts, Functional Risk Assessments, Validation Summary Reports, etc. associated with the validation and maintenance of computerized systems
Write, or contribute to, CSV deliverables Validation Plans, Functional Requirements, Test Scripts, Functional Risk Assessments, Validation Summary Reports, etc. associated with the validation and maintenance of computerized systems when applicable
Review procedures to ensure that the procedures contain the appropriate controls to ensure that computer systems are in a state of control
Provide management with updates on projects, health of the CSV process and communicate risk-based escalation issues, when applicable
Support resolution of CSV deviations/errors and provide compliance oversight to software validation projects
Project manage other external resources for CSV -related activities
May write, contribute to or edit, as appropriate, SOPs related to the validation of GxP computer systems and/or the use or administration of the validated system(s)
May assist in the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems
Works closely with IT and software/system vendor(s)as needed, to ensure user/design materials and test documentation can be leveraged and is acceptable
Applies knowledge of Cloud-based, SaaS systems, thoroughly interprets CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements
Liaises with IT and other cross-functional business teams to ensure that Solvias electronic systems for issue management and general IT compliance support
Qualification
Required
Bachelor's degree in technical, scientific or other relevant academic discipline and a minimum of 5 years of experience in a pharmaceutical, biotechnology or related environment combined with a minimum of 3 years of experience in oversight or management of GxP Computer System validation (or equivalent experience and/or education)
Demonstrated knowledge and understanding of applicable GxP or regulatory authority regulations and guidance activities and compliance (such as GCP, GPvP, GLP, GMP, GAMP, Part 11, Annex 11, ICH E6, OECD, etc.)
Demonstrated ability to lead and perform computer system QA audits and oversight of validation activities
Preferred
Experience in a CRO/CDMO is strongly preferred
Experience in a site start-up is strongly preferred
Ability to influence without direct authority
Excellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Knowledge of word-processing, spreadsheet, and database applications
Knowledge of pharmaceutical research and development processes and regulatory environments
Considerable knowledge of quality assurance processes and procedures and industry expectations
Strong interpersonal skills
Experience with computerized systems implementation, CSV program implementation, and acting as a subject matter expert for audits and inspections
Company
Solvias
Solvias provides contract research, development, and manufacturing for the pharmaceuticals, biotech, medical devices and cosmetics industry
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Archie Cullen
Chief Executive Officer
Jarlath Keating
President
Recent News
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