jobs in Bio Tree Pharmaceutical (Int'l) Sdn Bhd

全职 QA EXECUTIVE 工作, 薪水 up to MYR 3,500, Bio Tree Pharmaceutical (Int'l) Melaka 公司招聘中 - Ricebowl

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工作地点

  • Melaka Malaysia

职位描述

岗位职责

  • To maintain, control and distribute all quality-related documentation (SOPs, forms, BMR, BPR, records) in compliance with GMP and GDP principles, including revision updates.
  • To execute for the preparation, revise, issuance, and control Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) in compliance with GMP requirements.
  • To coordinate compliance-related training, including GMP refresher and SOP training.
  • To maintain training records and monitor training effectiveness.
  • To maintain the Training Need Analysis and Internal Training Plan for all department.
  • To manage change control process to ensure all changes are evaluated, approved, and implemented according to GMP.
  • To oversee investigation and documentation of deviations, incidents, and non-conformances.
  • To manage CAPA system, ensuring timely closure and effectiveness checks.
  • To execute and investigate customer complaints, coordinate with production/QA/QC for root cause analysis and corrective actions.
  • To execute and manage Out of Specification (OOS) and Out-of-Trend (OOT) investigations in coordination with QC/Production.
  • To coordinate and manage product recall activities, including documentation, reporting, and regulatory communication when required.
  • To coordinate, support, and participate in internal, external, and regulatory audits, including audit scheduling, preparation, facilitation, and follow-up actions.

Pay: RM2,500.00 - RM3,500.00 per month

Benefits:

  • Free parking
  • Maternity leave

Work Location: In person

重要安全守则

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