I will write gmp batch records, validation protocols, deviation capas, and sops

Man Li

China

I speak English, Chinese

Clinical Research Associate GCP Clinical Trial Documentation Specialist

I am a Clinical Research Associate (CRA) with 5 years of experience across global pharmaceutical and CRO studies - oncology, diabetes, dermatology, ophthalmology and more. I help international clients...
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About this Gig

FDA pre-approval inspection next month, but your batch records don't meet 21 CFR Part 211 standards. I deliver audit-ready GMP documentation batch records, validation protocols, deviation reports, CAPAs, and SOPs written from scratch around your specific process and equipment. No templates recycled from a different product line. No locked PDFs.

I work with pharma/biotech QA teams prepping for FDA/EMA/Health Canada inspections, CMO/CDMO facilities needing site-specific SOPs, and startups building their GMP quality system from scratch. Every document is structured so your QA team can review in hours, not days.

What you get

- Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) process-specific, not generic

- Validation protocols (IQ / OQ / PQ) compliant with FDA 21 CFR Part 211 and EU GMP Annex 15

- Deviation reports with root-cause analysis framework (fishbone / 5-why)

- CAPA plans corrective and preventive action documentation

- GMP SOPs aligned with ICH Q10 Pharmaceutical Quality System (PQS)

- Audit-ready binders structured for rapid QA review

Why buyers choose me

- 5 years of pharma & CRO quality experience applying ICH Q7, Q9, Q10 in real audit scenarios

- Pharma

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write gmp batch records, validation protocols, deviation capas, and sops
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write gmp batch records, validation protocols, deviation capas, and sops

Service type:

Research

Language:

Albanian

•

English

Delivery style preference

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