Computer System Validation (CSV) lead is accountable for managing the CSV validation activities for GxP applications for our biopharmaceutical client.
This is an individual contributor role, responsible for managing CSV projects and partnering with Business Owners, IT, and QA to manage the computer systems’ lifecycle and implement integrated electronic systems that improve the effectiveness, efficiency, and compliance across the client’s GXP operations.
- Contribute to developing the computerized systems validation strategy, including stage gate deliverables
- Plan and manage assigned CSV projects; author, review, and approve applicable CSV documentation
- Ensure the validation of computerized systems used across GxP operations is conducted in compliance with applicable regulatory requirements and internal procedures
- Effectively partner with Business Owners, IT, and QA to ensure compliant management of the computerized systems lifecycle
- Conduct impact assessments for changes impacting validated computerized systems
- Maintain the inventory of all computerized systems and requalification/revalidation schedules
- May oversee external CSV contractors, including training, assignment of projects, and ensuring the timely completion of their deliverables
- Track CSV deliverables and provide periodic progress reports to management and stakeholders at the client site
These are not requirements but describe someone who might be a great fit at Qualtivate.
- Bachelor's degree in a life sciences or Engineering discipline and a minimum of 3 years of relevant biotechnology or pharmaceutical industry experience.
- 3+ years of direct experience with CSV activities, strong knowledge of GAMP, risk-based approach to validation, and a good understanding of electronic records and signatures.
- Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations related to control of computerized systems, electronic records, and electronic signatures.
- Expertise in the development of CSV documentation (Validation Plans, Requirements, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs).
- Familiar with diverse computerized systems: ERP, LIMS, Validation Lifecycle Software, QMS, Learning Management System, SAS, CTMS, eTMF, Safety Database.
- Experience in developing CSV methodology for implementing and maintaining Infrastructure (IaaS), Platform (PaaS), and SaaS systems.
- Working experience with Quality Management System (e.g. Deviations, CAPAs, Change Management).
- Familiar or willing to learn business software to foster collaboration in a remote working environment. At Qualtivate, we use Google Suite, Notion, Airtable, Zapier, Slack, and other SaaS products to manage information and communication.
Email firstname.lastname@example.org with:
- Answers to the below questions:
- What is your unique strength?
- What is one area you’d like to improve in the next year?
- What’s your favorite QMS- related topic to nerd out on and why?
If we think you might be a good fit, we will respond within 5 days. In the meantime, you can check out our website to learn more about the projects we are working on and browse through posts on our blog and social media.