Overview
Skills
Job Details
Must have: Pharma/Biotech/Medical Device, IQ/OQ/PQ, GxP / cGMP, Commissioning and Qualification
Background:
The Radioligand Therapy (RLT), Carlsbad site is installing new instruments and software in the laboratory that will require validation work for the new QC lab.
As a part of the onboarding of new QC equipment and instruments for the project, multiple QC instruments, and QC support equipment will require validation/qualification work to meet QC testing demands. Equipment including but not limited to:
UPLCs
Dose Calibrators
Air Samplers
Particle Counters
Endosafe PTS
iTLC Scanner
Balance
pH Meter
General Requirements:
1. The work is subject to the terms and conditions of the vendors Master Agreement.
2. All work will be at the direction of Novartis staff
4. Weekly progress reports to be submitted to Novartis and include a weekly deliverables list, progress against plan (schedule) late tasks, risks, issues, and a 2 week look ahead.
5. All Work in Progress (WiP) shall be stored on the Novartis Team / Sharepoint sites
6. All documents and information are to be considered Confidential.
2 persons to provide validation support which shall include but not limited to the following items:
Provide support for Commissioning and Qualification activities for the required additional equipment and instruments.
Author and execute Commissioning and Qualification documents, including, but no limited to:
o URS
o Qualification Plans
o Development Protocols
o Risk Assessments
o Qualification Protocol(s) including deviation support during physical execution
o Qualification Reports
Collaborate and work directly with Carlsbad team members to complete project deliverables. Ensure to stay informed on general project information including but not limited to decisions, changes, plans of work, due dates, and issues.
Attend project meetings related to implementation, document reviews, and schedule reviews
Track deliverables and milestones and escalate delays to Validation Management
Escalate project or technical changes, issues, risks, and outstanding decisions to Validation Management
Requirements:
Bachelor's degree
3-5 years of related experience required