Boston - MA, USA
CSV / QA Manager
PQE Group is a Contract Quality Organization and a Complete Quality Solution provider for GCP, GLP, GMP & GDP areas in the Life Science Industry. Since 1998, we have successfully completed more than 7,000 projects worldwide and now serve our Clients from offices in Italy, Spain, Switzerland, Germany, LATAM, USA, the Middle East, China, India and Japan. As an international group we have experience working in more than 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities. PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for our Clients.
PQE is currently looking for a CSV/QA Validation manager willing to join one of our local projects in Boston (MA).
- Follow Computerized Systems Validation (CSV) process and Software Development LifeCycle (SDLC) methodology to build out and qualify the application.
- As application SME, work with infrastructure teams to request server architecture, and perform installation of application.
- Directly responsible for deployment, as well as authoring IT validation documents such as System Design and Configuration Specifications (SDCS’s) and Installation Qualifications (IQ), Backup Configuration and Restore Protocols, and System Administration Procedures.
- Assist with and provide input as SME and System Owner for other documents in validation process, such as User and/or Functional Requirements, Risk Assessments, Operational Qualification related to software functions, etc.
- Familiar with Quality Change Management software such as TrackWise, to document activities during the project and provide impact assessments.
- Can easily decipher from a lab system where data objects are stored and how its protected (main data, audit trail, methods, reports, templates, etc.). As a result, being able to develop data flow diagrams that also tie to how a system will be used.
- Work with infrastructure teams to assure proper backups of Lab systems are setup.
- Use various IT tools such as windows NTFS permissions, active directory, group policies, etc. to implement and deploy systems with data integrity risks minimized.
- Deploy workstations and install applications on both client and servers as needed for application.
- As incidents come in, work on troubleshooting and resolving issues for end users for sire applications, keeping senior members informed.
- Contacting vendors as needed for troubleshooting and resolving issues.
- Creation of user accounts in applications as needed following administration procedures.
- 10+ experience as Validation Manager
- QMS experience ( CVS- CAPA- Deviations) to help them building their QMS and processes
- Cross functional CSV knowledge for IT systems – but main focus on PV (Pharmacovigilance and R&D systems, such as Veeva)
- Valid US work authorization
- Willingness to work fulltime in Boston
- Valid US work permit
If interested, please send your resume clicking the button on the left of this page.
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