QC Systems Validation Specialist – Pharma/ Contract

Manpower Singapore

Singapore

On-site

SGD 90,000 - 120,000

Full time

11 days ago
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Job summary

Manpower Singapore is seeking a QC Systems Validation Specialist to support implementation and ongoing maintenance of QC GxP systems within a pharmaceutical manufacturing environment. The role focuses on qualifying critical QC instruments including environmental monitoring air samplers and particle counters, with emphasis on equipment validation and regulatory compliance.

The candidate should have 5–7 years in QC raw material testing, experience in method validation/verification, and a solid

Qualifications

  • Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life sciences/technology.
  • At least 5-7 years of experience in QC raw material testing.
  • Experience in method validation/verification in pharma/biotech.
  • Good understanding of GLP, GxP documentation and data integrity requirements.
  • Experience in startups will be ideal.

Responsibilities

  • Write and/or execute IQ and OQ test protocols for QC Laboratory computerized systems/equipment, including exception reports.
  • Author Qualification Summary Report for QC Equipment.
  • Author QC systems procedures such as SOPs and configuration specifications.
  • Partner with QC to conduct data integrity risk assessment.
  • Support the implementation and maintenance of QC GxP Systems in line with standards and regulatory guidance.

Education

Bachelor's/Master's Degree in Life Sciences/Pharmacy

Job description

About the role

QC Systems Validation Specialist supporting the implementation and maintenance of QC GxP Systems in a pharmaceutical manufacturing environment. The role focuses on qualifying critical QC instruments such as environmental monitoring air samplers and particle counters, with expertise in equipment validation and compliance with regulatory guidance.

Key responsibilities

  • Write and/or execute IQ and OQ test protocols for QC Laboratory Computerized systems/electronic equipment, including writing of exception reports

  • Author Qualification Summary Report for QC Equipment

  • Author QC Systems associated procedures such as administrative SOPs and configuration specifications, as required

  • Partner with QC to conduct data integrity risk assessment

  • Support the implementation and maintenance of QC GxP Systems in compliance with company's Standards and Regulatory guidance

About you

  • Bachelor's or Master's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology or related life Sciences or Technology

  • At least 5-7 years of experience in QC raw material testing

  • Experience in method validation/verification in the pharmaceutical or biotechnology industry

  • Good understanding of good laboratory practices, good documentation practice and data integrity requirements

  • Experience in start-ups will be ideal

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