QA Filling Analyst

7 hours ago

General Santos P, Philippines Century Pacific Agricultural Ventures Inc. Full time ₱900,000 - ₱1,200,000 per year

Job Summary

The QA Filling Analyst plays a key role in ensuring that filling operations are conducted in compliance with current Good Manufacturing Practices (cGMP), internal quality standards, and regulatory requirements. This position involves on-the-floor quality oversight of sterile and non-sterile product filling activities, line clearance verifications, real-time batch record review, and deviation documentation.

Key Responsibilities:

  • Provide real-time QA oversight on the manufacturing floor during filling and packaging operations.
  • Perform line clearance checks and ensure compliance with approved procedures before production start.
  • Review batch production records (BPRs) and associated documentation for completeness, accuracy, and GMP compliance.
  • Ensure adherence to SOPs, cGMP, and other regulatory requirements during filling and inspection processes.
  • Identify, document, and escalate deviations, non-conformances, or quality events.
  • Participate in root cause investigations and assist in defining corrective and preventive actions (CAPAs).
  • Conduct in-process checks (e.g., visual inspections, fill volume verification, torque tests) and verify critical process parameters.
  • Support readiness for regulatory inspections and internal audits by maintaining accurate documentation and data integrity.
  • Collaborate closely with Production, Engineering, and Quality Control teams to ensure quality is built into the process.
  • Monitor gowning compliance, aseptic practices (if applicable), and environmental conditions in classified areas.

Qualifications:

  • Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Biotechnology, or related field.
  • 1–3 years of QA or manufacturing experience in a regulated industry (pharmaceutical, biotech, or medical devices preferred).
  • Solid understanding of GMP, GDP, and regulatory requirements (e.g., FDA, EMA, MHRA).
  • Strong documentation and attention to detail.
  • Effective verbal and written communication skills.
  • Ability to work in a cleanroom environment, sometimes requiring gowning and extended standing periods.

Job Type: Full-time

Benefits:

  • Additional leave
  • Company events
  • Free parking
  • Health insurance
  • Life insurance
  • Pay raise
  • Promotion to permanent employee

Work Location: In person

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