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Regulatory Affairs Staff / CEZ, Rosario, Cavite

SAGASS ConsultingRosario, Cavite, PH

30+ days ago

Job description

Bachelor’s Degree in Pharmacy

Licensed Pharmacist (with or without work experience).

Regulatory Knowledge : Understanding of ISO standards (ISO 13485) and FDA regulations (preferred for applicants with prior RA experience).

Documentation and Compliance : Strong skills in technical writing and document management.

Data Analysis and Reporting : Proficiency in Microsoft Excel, including advanced functions.

Risk Management : Familiarity with risk assessment methodologies (e.g., FMEA), particularly for applicants with RA experience.

QMS Knowledge : Experience with Quality Management Systems (preferred).

CAPA / NCR Handling : Ability to manage Corrective and Preventive Actions (CAPA) and Non-Conformance Reports (NCR), especially for applicants with RA experience.

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Cavite Rosario Cavite • Rosario, Cavite, PH