QA Manager

Mundipharma; Jakarta Pusat; On-site; IDR 240,000,000 - 420,000,000; Full time

Job summary

Mundipharma in Jakarta seeks a QA professional to ensure product quality and regulatory compliance. The role focuses on handling complaints, product release, recalls, and maintaining QMS documentation to ensure traceability.

With a Bachelor's in Pharmacy or related field and an active STRA license, you will drive quality improvements, coordinate with health authorities, and monitor CAPAs and deviations within 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.

Responsibilities

• Handle and resolve product complaints efficiently and effectively.
• Oversee the release of products, ensuring they meet 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.

Skills

Quality Assurance

Regulatory Knowledge

Communication

Organizational Skills

Detail Orientation

Education

Bachelor's degree in Pharmacy or related field

Active Competency and STRA License

Job description

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)