Upstream Lead

Upstream Lead - US, North Carolina - 7 Months Initial Contract

Our client, a global pharmaceutical manufacturing organization, is looking for a talented CQV Upstream Lead to join their expanding team. With continued organizational growth and considerable investment across their portfolio of capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

• Lead CQV for all Upstream systems (Inoc, Media, Cell Culture, Harvest), responsible for timely review and approval of all CQV documentation including DQ/IQ, SIA, FAT, RTM, QRA, RVQ, SAT, IOC, TOC and final Reports.
• During BOD Stage, review all design deliverables, including drawings, datasheets, specifications and engineering lists, and assist in GMP reviews.
• Author all CQV sub plans (VPP) for Upstream areas.
• Review all GMP-generated documentation via the validation system.
• Liaise with the CMMS Team from day one to ensure timely transition of GMP information into the CMMS system.
• Align with Construction Management vendor and CQV Turnover Lead regarding system boundaries and lead the review exercise.

• Extensive CQV Upstream equipment experience on large-scale projects.
• SME on all Upstream Systems.
• Working knowledge of ASTM E2500/Leveraging Verification process.
• Experience liaising with other departments and building PMs/leads.