Technical Writer II (Pharma)

SGS (Malaysia) Sdn Bhd; Philippines; On-site; PHP 420,000 - 620,000; Full time

Job summary

SGS (Malaysia) Sdn Bhd is seeking a Technical Writer (Level I) to compile accurate scientific reports from validated data and ensure consistency across analytical techniques. The role includes executing test scripts for software re-validation and assisting with SOP and form revisions.

The ideal candidate holds a chemistry-related degree with at least two years of experience in pharma settings, familiarity with cGMP/ICH guidelines, and strong MS Office skills.

Qualifications

• Bachelor's degree in chemistry or related science field.
• Minimum 2 years' experience in scientific data entry and report creation.
• Knowledge of cGMP and ICH guidelines.

Responsibilities

• Compile scientific reports from validated data and ensure accuracy.
• Crosscheck data across analytical techniques for consistency before finalizing reports.
• Execute predefined test scripts for software revalidation and document results.
• Prepare and review SOPs, testing worksheets, and forms.
• Assist in documenting changes to compendia and communicate updates to relevant departments.

Skills

English proficiency

Attention to detail

Time management

Communication skills

Education

Bachelor's degree in chemistry or related science

Tools

Microsoft Office

Job description

Job Description

Primary Responsibilities
As a member of the team in our Global Business Solutions (GBS) center, the Technical Writer (Level I) will be responsible for compiling accurate scientific reports using validated data from analytical instruments. Verify data consistency across techniques, identify and report discrepancies.
Additionally, execute predefined test script for regular software re-validation, and report test outputs.
Assist in the revision, creation, review and approval process for appropriate department SOPs, testing worksheets, and forms.

Qualifications

Specific Responsibilities
Compile scientific reports using validated data from various analytical instruments. Produce clear, structured, high‑quality documentation following scientific conventions and internal templates.
Crosscheck and verify data consistency across different analytical techniques to ensure results logically correspond before report finalization. Report on anomalies in the outputs.
Execute predefined test scripts as part of scheduled software revalidation activities, accurately documenting and reporting all resulting outputs. Identify and report discrepancies observed during testing. Perform retesting once updates have been applied.
Document analytical findings by compiling data into standardized report templates.
Review the compendia updates (e.g., EP, USP), document changes, and communicate updates to relevant departments.
Assists with writing and reviewing testing worksheets, protocols and reports. Ensure approval for department SOPs, worksheets, and forms. Perform spreadsheet validations according to SOP.
Performs other related duties as may be assigned either in support of departmental goals or for his/her personal or professional training, education or development as programmed by his/her immediate superior.
At all times, comply with SGS Code of Integrity and Professional Conduct and with all SGS QHSE and HR policies and procedures. Ensure the work area in GBS is always clean and presentable.

Profile
Bachelor's degree in chemistry or a related science field (e.g. pharmacy).
Minimum 2 years of relevant experience (in scientific data entry and report creation and/or in laboratory testing), in pharma setting is required.
Demonstrated understanding of cGMP and/or GcLP regulations is required.
Good understanding of analytical methods, knowledgeable in all regulatory guides such as ICH M10, pharmacopeias (EP, USP), preferrable.

Additional Information

Required Skills
Strong command of the English language (B2 as minimum), with good verbal- and written communication skills (grammar and composition).
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook).
Strong interpersonal skills and the ability to work both collaboratively and independently.
Proven time management skills and meticulous attention to detail.