QA Specialist

2 days ago

San Fernando, Central Luzon, Philippines Drugmaker's Laboratories Inc. Full time ₱900,000 - ₱1,200,000 per year

Job Summary:

We are looking for a highly organized and detail-oriented Quality Assurance Specialist with a solid background in the pharmaceutical industry. The successful candidate will be responsible for ensuring that all processes and products comply with Good Manufacturing Practices (GMP), regulatory standards, and internal quality policies. This role requires strong analytical skills, a proactive attitude toward problem-solving, and the ability to maintain accuracy and consistency in documentation and compliance activities.

Qualifications:

  • Graduate of BS Pharmacy, Applied Science, or Chemical Engineering — must possess a strong academic foundation in science and technical knowledge applicable to pharmaceutical operations and regulatory compliance.
  • Experience in QA/QC or Regulatory Affairs is preferred — familiarity with GMP, GLP, and ISO standards is a strong advantage.
  • Knowledge in Dossier Preparation and Regulatory Submission — experience with FDA documentation, product registration, and other regulatory filings is an asset.
  • Strong Analytical and Problem-Solving Skills — capable of interpreting data, identifying root causes, and providing effective corrective and preventive actions.
  • Excellent Communication Skills — proficient in both written and verbal English, able to draft reports, prepare documentation, and coordinate effectively with internal departments and regulatory agencies.
  • Computer Literate — proficient in Microsoft Word, Excel, and PowerPoint, with the ability to maintain organized and accurate documentation.
  • Highly Organized and Detail-Oriented — able to manage multiple tasks while ensuring compliance, consistency, and accuracy in all outputs.
  • Self-Motivated and Collaborative — can work independently with minimal supervision while contributing positively to a team-driven environment.

Key Responsibilities:

  • Ensure compliance with GMP, company quality policies, and regulatory standards by monitoring daily operations, performing quality checks, and providing necessary guidance to maintain consistent product quality.
  • Prepare, review, and maintain regulatory submissions such as FDA applications, product registration documents, and other compliance-related filings to ensure accuracy, completeness, and timely submission.
  • Develop, review, and maintain QA documentation including audit reports, validation records, deviation logs, and quality compliance reports in accordance with internal and external standards.
  • Support Corrective and Preventive Action (CAPA) processes by investigating non-conformances, identifying root causes, and coordinating with relevant departments to implement effective solutions.
  • Draft, review, and update Standard Operating Procedures (SOPs) and quality manuals to reflect current industry practices, regulatory updates, and internal process improvements.
  • Coordinate with cross-functional teams such as Production, QC, Regulatory, and R&D to ensure alignment and timely resolution of quality-related issues.
  • Participate in internal and external audits by preparing documentation, addressing findings, and contributing to continuous improvement initiatives that enhance quality compliance and operational efficiency.

Job Type: Full-time

Work Location: In person

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