I will write gmp compliant sops and pharmaceutical documents

Are you preparing for a GMP audit and struggling with documentation?

I help pharmaceutical manufacturers, API producers, and nutraceutical companies create audit-ready SOPs, CAPA frameworks, BMR/BPR templates, and QMS documents written by someone who has actually worked on the shop floor and in QA.

My background:

3 years in pharma QA/QMS across API manufacturing and formulation

Hands-on experience with SEDEX customer audits, CAPA, OOS/OOT investigations, and change control

Trained in ICH Q7, Q9, Q10, ALCOA++, and Schedule M (Revised)

I can write SOPs for:

• CAPA & Deviation Management
• Change Control
• OOS / OOT Investigation
• Cleaning Validation & Equipment Qualification
• BMR / BPR Review
• Vendor Qualification & Audits
• Data Integrity & ALCOA++
• Warehouse, QC Lab, Production any GMP area

All documents follow GMP formatting standards and are delivered as fully editable Word files. I understand what auditors look for because I've been on both sides of the process.

Message me before ordering if you have a specific topic or audit deadline I'll tell you exactly what I can deliver.