I will write gmp compliant sops and pharmaceutical documents

Sommige informatie wordt in het Engels weergegeven.

India

Ik spreek Engels

Pharma QA professional with 3 years in GMP regulated API And formulation

I help pharma and API manufacturers build audit-ready QMS systems. With 3 years across production, QA, and QMS roles in GMP-regulated facilities, I deliver SOPs, CAPA frameworks, validation protocols,...

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Over deze dienst

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.

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