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QA Manager

JakartaOn-siteFull-time

AI Summary

Manages product quality and compliance for pharmaceutical distribution, handling complaints, recalls, and regulatory reporting.

About this role

OMQ-P3-12

Responsibilities:

  • Handle and resolve product complaints efficiently and effectively.
  • Oversee the release of products, ensuring they meet all quality and compliance standards.
  • Manage and coordinate product recalls, ensuring swift and compliant resolution.
  • Maintain and update QMS documentation, including archiving and retention, to ensure compliance and traceability.
  • Prepare and submit reports to health authorities as required by applicable regulations.
  • Monitor and ensure the closure of Change Controls, CAPAs, and Deviations within the stipulated timelines.

Qualifications:

  • Bachelor’s degree in Pharmacy or related field.
  • Active Competency and STRA License.
  • Proven experience in quality assurance within the pharmaceutical industry.
  • Strong knowledge of Good Distribution Practices and relevant regulations.
  • Excellent organizational and communication skills.
  • Detail-oriented with a strong focus on compliance and quality.


Additional Job Description:

Primary Location:

ID Jakarta

Job Posting Date:

2024-09-18

Job Type:

Fixed Term Contract (Fixed Term)

Skills

CAPAChange ControlsDeviationsGood Distribution PracticesHealth Authority ReportingPharmaceutical Quality AssuranceProduct RecallsQMS DocumentationRegulatory ComplianceSTRA License

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