GMP Validation & Compliance Specialist

Asset Recruitment

Carlow

Hybrid

EUR 65,000 - 90,000

Full time

3 days ago
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Job summary

Asset Recruitment is recruiting a Validation Compliance Specialist for a leading pharmaceutical company at the Carlow site in Ireland. The role focuses on providing compliance support across validation activities, maintaining the Validation Master Plan, and ensuring adherence to cGMP and regulatory requirements.

You will work independently and cross-functionally to meet validation and compliance objectives, with emphasis on documentation, audits, and continuous improvement within a GMP

Qualifications

  • Experience in GMP manufacturing environments and independent work.
  • Proven capability in deviation management and change control.
  • Experience with equipment validation lifecycle and periodic validation.
  • Knowledge of process monitoring, automation systems (DeltaV) and data systems (Pi System).

Responsibilities

  • Provide compliance support for validation activities.
  • Support regulatory, divisional and internal audits.
  • Maintain site Validation Master Plan and governance reports.
  • Review validation documentation for accuracy and compliance.
  • Coordinate revalidation plans and annual product review chapters.
  • Assist risk assessments and CAPA activities; ensure GMP compliance.

Skills

Deviation management
Change control
GMP manufacturing
Project management
Validation documentation
Communication skills

Education

Applied Pharmaceutical/ Biological/ Chemical sciences or Engineering

Tools

DeltaV
Pi System
Microsoft Office

Job description

Asset Recruitment is recruiting a Validation Compliance Specialist for a leading pharmaceutical company at the Carlow site in Ireland. The role focuses on providing compliance support across validation activities, maintaining the Validation Master Plan, and ensuring adherence to cGMP and regulatory requirements.

You will work independently and cross-functionally to meet validation and compliance objectives, with emphasis on documentation, audits, and continuous improvement within a GMP

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