QA / Regulatory

4 weeks ago

Cavite City, Philippines Kimiki Solutions Incorporated Full time

The QA/Regulatory Specialist is responsible for ensuring that products, services, and processes comply with internal and external quality standards, as well as government and industry regulations. This role involves maintaining documentation, conducting audits, managing regulatory submissions, and working closely with cross-functional teams to ensure that regulatory compliance is met throughout the product lifecycle

  • Bachelor’s degree in Life Sciences, Engineering, or a related field (Pharmacist).
  • Proven experience in Quality Assurance and/or Regulatory Affairs, particularly in industries like pharmaceuticals, medical devices, or biotechnology.
  • In-depth knowledge of FDA regulations (21 CFR Part 820, Part 11, etc.), ISO standards (e.g., ISO 13485), and other regulatory requirements.
  • Strong understanding of GxP (Good Manufacturing Practices), GMP, GLP (Good Laboratory Practices), and QMS.
  • Ability to interpret and apply regulatory guidelines to daily operations.
  • Excellent communication, organizational, and problem-solving skills.
  • Familiarity with regulatory submission processes and document control systems.
  • Certification in regulatory affairs (e.g., RAC - Regulatory Affairs Certification) or quality management (e.g., CQE - Certified Quality Pharmacist) is a plus.
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