I will write audit ready pharmaceutical validation documentation

M
malvaez95
M
malvaez95
Javier Malvaez
write audit ready pharmaceutical validation documentation
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write audit ready pharmaceutical validation documentation

About this gig

I write validation documentation for pharmaceutical plants, laboratories, and contract manufacturers that need clear, technical documents ready for FDA, EMA, or other health authority inspections.

What I can prepare:

  • Cleaning validation protocols and reports
  • Continued Process Verification (CPV / Stage 3)
  • Computerized System Validation (CSV, GAMP 5)
  • Laboratory equipment classification per USP 1058
  • Risk assessments per ICH Q9(R1)
  • Validation SOPs: drafting and review

How I work:

  • I start from your data (equipment, products, limits) and build the document with justified acceptance criteria.
  • Every deliverable includes a first draft and revisions, as set in each package.
  • I keep traceability between risk, test, and acceptance criterion, so the document stands up to an audit.
  • All work is confidential.


Get to know Javier Malvaez

Javier Malvaez
4.6(18)
  • FromMexico
  • Member sinceAug 2019
  • Avg. response time1 hour
  • Last delivery1 year

  • Languages

    Spanish
Experience in the pharmaceutical industry, calculation and design of reactors of all kinds. Short circuit calculation, electrical engineering drawings. Chemical Engineer with experience in the pharmaceutical, oil and electrical industries. Experience in critical systems for the pharmaceutical industry, HVAC, compressed air, purified water, etc. Calculation memories for critical systems, optimization of resources to reduce operating costs in the pharmaceutical industry.

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