Quality Records Team Lead

Quality, Management, System, Change Management, Validation, Protocols, Documentum, ERP, Oracle, Windows, Linux
Full Time
Travel not required

Job Description

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 hiring/developing 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 reviewing/approving Deviation, CAPA, and Change Management Quality Management System (QMS) records
  • Working experience creating or reviewing/approving computer system validation (CSV) deliverables (Validation Plans, User/Functional 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, Windows/Linux 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

#RecruitPS
Dice Id : 90764204
Position Id : 375
Originally Posted : 9 months ago
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