Quality Assurance Analyst

21 hours ago

San Pedro, Calabarzon, Philippines Drugmaker's Laboratories, Inc Full time ₱800,000 - ₱1,200,000 per year
Job Summary:

We are seeking a detail-oriented Quality Assurance Specialist with a strong background in the pharmaceutical industry. The role is responsible for ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company quality protocols to uphold the integrity of our products and processes.


Qualifications:
  • Graduate of BS Pharmacy, Applied Science, or Chemical Engineering – Solid academic foundation in science and technical knowledge relevant to pharmaceutical operations.
  • Experience in QA/QC or regulatory functions preferred – Familiarity with pharmaceutical standards and compliance requirements is a strong advantage.
  • Dossier preparation and regulatory submission experience – Knowledge of documentation and regulatory filings is a plus.
  • Strong analytical and problem-solving skills – Ability to evaluate data, identify issues, and recommend effective solutions.
  • Excellent communication skills in English – Proficient in writing reports, preparing documentation, and coordinating with internal and external stakeholders.
  • Computer literate – Skilled in Microsoft Office tools for documentation and reporting.
  • Highly organized and detail-oriented – Capable of managing multiple tasks and ensuring accuracy in all outputs.
  • Self-motivated and collaborative – Able to work independently while contributing effectively to team projects.

Key Responsibilities:
  • Ensure GMP and internal quality compliance by monitoring operations and providing guidance.
  • Oversee regulatory submissions such as FDA applications and product registrations, ensuring accuracy and timeliness.
  • Maintain QA documentation including audits, reports, and compliance records.
  • Support CAPA activities by helping identify issues and implementing improvements.
  • Draft and update SOPs and manuals to reflect current standards and practices.
  • Coordinate with cross-functional teams to resolve quality-related concerns.
  • Participate in audits and inspections to strengthen compliance and continuous improvement initiatives.

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