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Employer Fastnet The Talent Group
Job Title Inspection Readiness Manager
Description

Responsibilities

  • Set-up an internal Compliance Programme within the manufacturing department.
  • Self-Inspection Programme
  • Management of GMP Records
  • Tracking and Reporting Systems
  • Escalation process
  • Full understanding of basic cGMP expectations; set a good example in observance of cGMP policies.
  • Interact with the Manufacturing floor staff regularly to answer questions related to GMPs and help champion a compliant work environment with a Continuous Improvement Focus
  • Implement local/global CAPAs, regulatory/audit recommendations, and general improvement projects.
  • Report on the timeliness of compliance to set timelines on Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
  • Managing Change Requests (CRs)
  • Work with Manufacturing staff and QA Change Control to contribute to comprehensive implementation plans for CRs
  • Product Change-Over
  • Work with Manufacturing leadership and staff to coordinate and organize product change-over activities and recommend future improvements.
  • Acquire fundamental knowledge of technical aspects of Media/Buffer Prep, Cell Culture and Purification operations
  • Comply with cGMP Documentation & Operations
  • Compliance with safety guidelines
Education

  • BA or BS in a technical discipline (physical or biological sciences preferred but not required)
  • 10 years experience within pharmaceutical manufacturing
  • Experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
  • Experience leading and implementing projects
  • Demonstrated ability to influence peers and teams with no direct reporting lines.
  • Ability to speak, present data, and defend approaches in front of a variety of audiences.
  • Organizational skills to contribute to department and cross-functional project
  • Familiarity with FDA & European GMP's and regulatory requirements, guidelines, and recommendations.
  • Strong proficiency with Trackwise
  • Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.
  • Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications.


Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

This job originally appeared on RecruitIreland.com
Location Cork
Date Added 59 days ago
Apply Link
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