Pharma Document Reviewer

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

About the role

Performs review and approval of data based on document review in a timely and effective manner according to methods, instructions, procedures, good laboratory documentation practices (GDP), good manufacturing practices (GMP) and standard operating procedures (SOPs).

Key responsibilities

• Assures that reviewed QC records are compliant to methods, specifications and company's applicable Standard Operating Procedure
• Ensures that documentation review is complete in every respect and verify that all results entered the electronic laboratory information system LIMS
• Assures records of Validation/Method Transfer/Verification and reports are as per protocol and method provided by clients or written by SGS
• Ensures test results are reported appropriately on either a CofA or a RofA depending on the validation/transfer status of the method
• Audits all record books (logbooks), calibration related documents, and other QC documents, associated with testing, reviewed / approved
• Requests deviation to be reported or issues a deviation report in case where method or SOP was not followed as written
• Informs analyst or his/her supervisor to initiate out-of-specification and/or issue OOS form in case of OOS, which was not noted by analyst
• Issues an audit form noting deficiencies to method and procedures, returns the form to analyst for correction according to Data Review SOP
• Revises forms for execution of methods and procedures; issues CCR for method change and new worksheet generation
• Identifies, participates in and sometimes leads operational improvement initiatives

About you

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