Production Sterile QMS Senior Officer

Diu - India

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Good exposure to Quality Management Systems in compliance with cGMP and applicable regulatory guidelines (USFDA EMA MHRA WHO etc.).
Experienced in preparing and reviewing QMS-related documents such as SOPs CAPA deviations change controls Risk assessment validation protocols and reports.
Proficient in MS Word MS Excel SAP and TrackWise systems.
Capable of responding to auditor queries during internal and external audits and implementing recommended actions.
Should have knowledge of sterile manufacturing processes (Vials PFS and Ophthalmic products).
Skilled in cross-functional collaboration with Production Engineering QA and other stakeholders to ensure timely closure of deviations change controls CAPAs and risk assessments thereby maintaining quality compliance in sterile manufacturing.

Required Experience:

Senior IC

Good exposure to Quality Management Systems in compliance with cGMP and applicable regulatory guidelines (USFDA EMA MHRA WHO etc.). Experienced in preparing and reviewing QMS-related documents such as SOPs CAPA deviations change controls Risk assessment validation protocols and reports. Profic...