Job Description

Recruiters please do not contact this job poster. Please be advised: Solvias does not accept unsolicited resumes or services from third-party recruitment agencies. In the event, a recruiter or agency submits a resume or candidate without an agreement we shall explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency. Any unsolicited resumes, including those submitted to Company employees, shall be deemed the property of the Company.

Solvias is a global provider of chemistry, manufacturing, and control (CMC) analytics to the life sciences industry. Our expert team combines decades of experience with regulatory expertise across small molecules, biologics, and cell and gene therapies. Solvias offers end-to-end solutions from raw material testing to drug product release and API development for small molecules. Headquartered near Basel, Switzerland, Solvias operates six global Centers of Excellence, all adhering to the highest ISO, GMP, GLP, and FDA standards.

Position Overview

Located at our large molecule headquarters in RTP, North Carolina, the Sr. Specialist, CSV position will join the Quality Assurance team in supporting quality operations for Large Molecule & Advanced Therapy Medicinal Products (ATMP) testing services in a Good Manufacturing Practices (GMP) laboratory environment.

This is a fully onsite role reporting to the Qualification Validation Manager.

Critical Performance Areas

• 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.

Essential Job Functions

• 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.

Requirements

• Bachelor's degree in technical, scientific or other relevant academic discipline and a minimum of5 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.

Other Desired Skills/Abilities

• 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.

NOTE: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

Disclaimer: Solvias North America, LLC does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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