Regulatory Affairs Staff

5 days ago

Rosario, Philippines SAGASS Consulting Full time

• 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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  • Regulatory Affairs Staff

    2 weeks ago

    Rosario, Philippines SAGASS Consulting Full time

    • 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...

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