Quality Records Team Lead
Company: Recruit Professional Services
Location: San Francisco
Posted on: August 3, 2020
Quality Records Team Lead We are currently seeking an
experienced and dedicated Quality Assurance Team Lead to work on
location in San Francisco to support one of our top clients.
Description This person will be responsible for Leading a
medium-sized team in support of the creation and maintenance of
Quality Management System records (e.g. training, coaching,
mentoring and hiringdeveloping people) Ensuring that the
documentation supporting change management records and CAPAs adhere
to 21 CFR Part 11, Annex 11, GMP (21 CFR Part 211), GAMP 5, GDP,
and applicable SOPs. Formally track Deviations, CAPA' s, and change
management records, to ensure KPIs are met in accordance with
agreed upon SLAs. Leading investigation of deviations, including
conducting and participating in investigation meetings, gather
information about the deviation (e.g. interview personnel, inspect
audit trail and documents), determination of root cause, and
proposing CAPA actions to address the root cause of the deviation.
Preparing CAPA Plans that include purpose, scope, risk mitigation
strategies, and clearly identify CAPA actions along with specific
deliverables required to complete the CAPA actions. Requirements 2
- 4 years experience leading teams 5 - 8 years' experience
validating GxP systems within the pharmaceutical, biotech, or
medical device fields Excellent communication skills (verbal,
written) able to communicate clearly at all levels of the
organization, including senior management Working experience
creating or reviewingapproving Deviation, CAPA, and Change
Management Quality Management System (QMS) records Working
experience creating or reviewingapproving computer system
validation (CSV) deliverables (Validation Plans, UserFunctional
Requirements, Design Specs, Qualification Protocols (IQ OQ PQ),
Summary Reports, Trace Matrices, SOPs) Familiar with one or more of
the following types of systems QMS (e.g. TrackWise), EDMS (e.g.
Documentum, Veeva Vault), Learning Management System (e.g.
ComplianceWire), ERP System (e.g. Oracle EBS), Virtualization (e.g.
VMware), computer infrastructure (e.g. switches, WindowsLinux
servers) Able to understand current work processes, as described in
Work Instructions, SOPs and policies Able to quickly develop
working knowledge of complex computer systems leveraging SMEs,
vendor documentation, and SOPs RecruitPSSDL2017
Keywords: Recruit Professional Services, San Francisco , Quality Records Team Lead, Other , San Francisco, California
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