Production Documentation Lead

Lupin; Florida; Sur place; USD 60 000 - 85 000; Plein temps

Résumé du poste

Lupin in Florida seeks a documentation specialist to manage and prepare GMP shop floor documents, SOPs, URS, protocols, and batch records. The role requires strong reading and writing of English technical documents and familiarity with GMP processes.

Candidates should have at least a high school diploma with 5+ years in a production cGMP environment and knowledge of FDA guidelines. The work includes maintaining safety standards and collaborating with cross-functional teams at Lupin.

Qualifications

• Proficiency in preparing SOPs, batch records, and related documents.
• Experience with cGMP documentation practices and regulatory guidelines.
• Ability to read and interpret safety rules and batch documentation in English.

Responsabilités

• Handle all types of shop floor documentation including batch documents and logbooks.
• Prepare SOPs, URS, change controls, protocols and qualification documents.
• Ensure timely completion and accuracy of GMP documentation and calibration records.

Connaissances

Documentation prep

SOP writing

Batch records

cGMP knowledge

FDA knowledge

Formation

High school diploma

Bachelor’s degree preferred

Outils

SAP

QMS

Description du poste

Lupin in Florida seeks a documentation specialist to manage and prepare GMP shop floor documents, SOPs, URS, protocols, and batch records. The role requires strong reading and writing of English technical documents and familiarity with GMP processes.

Candidates should have at least a high school diploma with 5+ years in a production cGMP environment and knowledge of FDA guidelines. The work includes maintaining safety standards and collaborating with cross-functional teams at Lupin.