Pharma GMP Documentation Lead

ttg Talent Solutions; Fort Lauderdale (FL); On-site; USD 95,000 - 135,000; Full time

Job summary

ttg Talent Solutions is seeking an experienced Production Documentation Lead for pharmaceutical manufacturing on-site in Florida. The role centers on creating, developing, and maintaining technical manufacturing documentation to meet FDA and cGMP standards.

The ideal candidate has hands-on experience writing GMP documentation from scratch, with focus on SOPs, MBRS, and manufacturing instructions, and works cross-functionally with QA, QC, Engineering, and Maintenance.

Qualifications

• Minimum 5+ years in pharma manufacturing documentation in a cGMP environment.
• Direct hands-on experience creating GMP documentation from scratch.
• Strong ability to develop SOPs, Batch Records, and manufacturing procedures.
• Experience contributing to deviations, change controls, and URS.
• Knowledge of FDA, cGMP, GDP and quality systems.

Responsibilities

• Create, revise, and maintain SOPs, MBRS, Batch Records and manufacturing instructions.
• Prepare URS, protocols, equipment qualification documents, and process documentation.
• Draft deviations, change controls, and other QMS documents.
• Maintain production-related records: logs, in-process docs, cleaning, equipment calibration, maintenance.
• Collaborate with Production, QA, QC, Engineering, and Maintenance to capture accurate technical information.
• Translate procedures and equipment needs into clear, compliant controlled documents.
• Support documentation for new equipment, process changes, and qualification activities.
• Ensure adherence to cGMP, GDP, FDA regulations and internal SOPs.

Skills

Technical writing

GMP documentation

SOP development

Cross-functional collaboration

Tools

SAP

MES

QMS software

Job description

ttg Talent Solutions is seeking an experienced Production Documentation Lead for pharmaceutical manufacturing on-site in Florida. The role centers on creating, developing, and maintaining technical manufacturing documentation to meet FDA and cGMP standards.

The ideal candidate has hands-on experience writing GMP documentation from scratch, with focus on SOPs, MBRS, and manufacturing instructions, and works cross-functionally with QA, QC, Engineering, and Maintenance.