GMP Compliance & Data Review Specialist

SGS Global Business Services Asia Inc.; Muntinlupa; On-site; PHP 600,000 - 900,000; Full time

Job summary

SGS Global Business Services Asia Inc. is seeking a Data Reviewer for pharmaceutical QC documentation. You will review and approve data in line with GDP, GMP and SOPs, ensuring accurate entry into LIMS and proper CofA/RofA reporting.

The role requires a Bachelor of Science in Chemistry or Microbiology and at least 5 years in a pharma lab, with strong English communication and proficiency in TrackWise Digital or other QMS and LIMS systems.

Qualifications

• Bachelor of Science in Chemistry or Microbiology or related science.
• Minimum 5 years' experience in a pharmaceutical laboratory.
• Demonstrated understanding of cGMP regulations.
• Knowledge of USP required; EP preferred, JP/BP advantageous.
• Experience with TrackWise Digital or any other QMS preferred.
• Working experience with LIMS systems preferred.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook).
• Strong written and verbal communication in English (B2+).
• Ability to manage and coordinate multiple projects in a fast-paced environment.
• Detail-oriented with the ability to identify minor discrepancies.

Responsibilities

• Assures QC records are compliant to methods, specifications and SOPs.
• Verifies documentation review and data entry into the electronic LIMS.
• Ensures validation/transfer/verification records and reports meet protocol and client method.
• Ensures test results are reported on CofA or RofA per status.
• Audits logbooks, calibration documents, and other QC materials.
• Requests deviations or issues deviation reports when SOPs are not followed.
• Informs analyst or supervisor to initiate OOS forms when necessary.
• Revises forms for execution of methods and issues CCR for changes.
• Identifies and leads operational improvement initiatives.

Skills

Strong written and verbal English (B2+

Project coordination

Attention to detail

Education

Bachelor of Science in Chemistry or Microbiology

Tools

LIMS

TrackWise Digital

Microsoft Office

Job description

SGS Global Business Services Asia Inc. is seeking a Data Reviewer for pharmaceutical QC documentation. You will review and approve data in line with GDP, GMP and SOPs, ensuring accurate entry into LIMS and proper CofA/RofA reporting.

The role requires a Bachelor of Science in Chemistry or Microbiology and at least 5 years in a pharma lab, with strong English communication and proficiency in TrackWise Digital or other QMS and LIMS systems.