Senior Validation Manager — Design Transfer & Compliance

PERSOL SINGAPORE PTE. LTD.

Singapore

On-site

SGD 78,000 - 112,000

Full time

2 days ago
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Job summary

PERSOL SINGAPORE PTE. LTD. is seeking an experienced Validation Manager to lead design transfer and validation in a highly regulated manufacturing environment in Singapore.

You will plan, execute, review, and document validation activities to ensure compliance with regulatory requirements, SOPs, and company quality standards. The role spans qualification of facilities, equipment, utilities, processes, cleaning, and computerized systems, with a focus on cGMP, cGDP, and ALCOA+ data integrity.

Qualifications

  • Bachelor's degree in engineering/science or related field.
  • 10+ years hands-on validation experience in regulated industries.
  • Experience validating facilities, equipment, utilities, processes, cleaning and computerised systems.
  • Knowledge of regulatory requirements, validation methodologies, and quality systems.
  • Familiarity with cGMP, cGDP, ALCOA+ data integrity.

Responsibilities

  • Plan, execute, review and document validation activities to ensure regulatory compliance.
  • Support design transfer validation and qualification of facilities, equipment, utilities, materials, processes, cleaning and computerized systems.
  • Review and approve validation protocols and reports.
  • Coordinate with cross-functional stakeholders to meet timelines.
  • Maintain validation records for inspections and audits.
  • Investigate validation issues and support CAPA implementations.
  • Ensure adherence to cGMP, cGDP and ALCOA+ data integrity principles.

Skills

Communication
Interpersonal skills
Analytical thinking
Problem solving
Prioritization

Education

Bachelor's Degree in Engineering/Science

Job description

PERSOL SINGAPORE PTE. LTD. is seeking an experienced Validation Manager to lead design transfer and validation in a highly regulated manufacturing environment in Singapore.

You will plan, execute, review, and document validation activities to ensure compliance with regulatory requirements, SOPs, and company quality standards. The role spans qualification of facilities, equipment, utilities, processes, cleaning, and computerized systems, with a focus on cGMP, cGDP, and ALCOA+ data integrity.

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