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I will create gmp compliant sops, checklists and templates
GMP Compliance und QA Expertise
I am a licensed pharmacist with over 3 years of experience in the pharmaceutical industry. In my role as a (Senior) QA Specialist for GMP Compliance, with a focus on CSV, data integrity, and qualifica...
About this Gig
As a Senior QA Specialist for GMP compliance with 3+ years of experience in the German pharmaceutical industry, I deliver professional, audit-ready documentation tailored to your regulatory needs. I specialize in SOPs, QA documents and checklists that meet EU GMP standards and support real-world operations.
You will receive: Clear, structured documents in Word/PDF
Proofreading, formatting, and optional citations
Packages tailored to your scope:
Basic: 1 short SOP or 3 checklists (300 words)
Standard: Up to 3 SOPs or QA docs (1500 words total)
Premium: Full GMP set risk assessment + SOPs (3500 words across multiple documents)
Each package includes revisions, optional addons are fast delivery, additional words and additional revisions.
Extended research is essential for complex GMP documentation and is therefore included in the Standard and Premium packages by default.
I combine regulatory precision with practical usability so your process is smart compliant and inspection ready.
Delivery style preference
Please inform the freelancer of any preferences or concerns regarding the use of AI tools in the completion and/or delivery of your order.
FAQ
What languages will be provided?
I can provide the documents in german or in english.
What types of QA documents do you offer?
I specialize in SOPs, QA documents, structured checklists, and risk assessments tailored to EU GMP standards. Special expertise lies within EU-GMP Annex 11 computerised systems.
Can you write documents for specific pharmaceutical processes or equipment?
Yes. I can tailor documents to your specific process, equipment, or site setup. Just provide the relevant details or existing templates, and I’ll align the content accordingly.
Do you include references or regulatory citations?
Yes, references and citations are included in Standard and Premium packages. These support audit readiness and regulatory clarity.
What’s the difference between your Standard and Premium packages?
Standard includes up to 3 SOPs or QA documents (1500 words total). Premium delivers a full documentation set — typically a risk assessment (~1000 words) plus matching SOPs (~2500 words), with deeper research and technical illustration.
Can I request revisions or updates after delivery?
Yes. All packages include revisions. You can also purchase additional revisions if needed. I aim for clarity, compliance, and client satisfaction.
Do you offer technical illustrations or flowcharts?
Yes, technical illustrations (e.g., process diagrams, risk matrices) are available in Premium packages or as add-ons. These enhance training and audit usability. I can not provide technical document (e.g. electric plans or layouts)
Is my information confidential?
Absolutely. All client data and project details are treated with strict confidentiality. I do not share or reuse any client specific content.
