Validation Engineer - Documentation & Compliance Execution

Pharmagend Global Medical Services Pte Ltd

Singapore

On-site

SGD 90,000 - 140,000

Full time

45 hours ago
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Job summary

Pharmagend Global Medical Services Pte Ltd seeks an experienced Qualification and Validation Specialist to lead planning, execution, and oversight of qualification activities for equipment, utilities and facilities.

You will coordinate with cross-functional teams, manage change controls, write SOPs, and ensure activities stay in a validated state per regulatory guidelines. A degree in a scientific discipline and 5–7 years in pharma manufacturing are preferred.

Qualifications

  • Degree in a scientific discipline.
  • 5–7 years' relevant experience in pharmaceutical manufacturing.
  • Knowledge of qualification/validation principles and their practical application.
  • Proficient with Microsoft Word, Excel, Access, PowerPoint, and Explorer.
  • Familiarity with regulatory/compliance environment.
  • Ability to interact and lead effectively in a team-based environment.
  • Experience in a regulated industry preferred.

Responsibilities

  • Prepare and review qualification documents (URS, DQ, IQ, OQ, PQ).
  • Execute qualification and validation activities across processes and facilities.
  • Prepare and review process and cleaning validation protocols and reports.
  • Coordinate with cross-functional teams and external service providers.
  • Review change controls and perform risk assessments to determine criticality.
  • Write, review, and revise validation SOPs complying with guidelines.
  • QA oversight during the validation process.
  • Manage incidents and deviations related to validation/qualification.
  • Perform compliance reviews of deviations, investigations, and CAPAs.
  • Suggest improvements to Validation Master Plan and validation strategies.

Skills

Team leadership
Regulatory compliance
Quality systems
Problem solving

Education

Degree in a scientific discipline

Tools

Microsoft Word
Microsoft Excel
Microsoft Access
PowerPoint
Explorer

Job description

Pharmagend Global Medical Services Pte Ltd seeks an experienced Qualification and Validation Specialist to lead planning, execution, and oversight of qualification activities for equipment, utilities and facilities.

You will coordinate with cross-functional teams, manage change controls, write SOPs, and ensure activities stay in a validated state per regulatory guidelines. A degree in a scientific discipline and 5–7 years in pharma manufacturing are preferred.

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