QA Manager

Mundipharma; Jakarta Pusat; Presencial; IDR 120.000.000 - 180.000.000; Jornada completa

Descripción de la vacante

Mundipharma in Jakarta is seeking a QA professional to ensure product quality from release to recall, while maintaining comprehensive QMS documentation for traceability and regulatory compliance.

The candidate will hold a Bachelor’s degree in Pharmacy with an active STRA license, and bring proven quality assurance experience in the pharmaceutical industry, complemented by strong GDP knowledge and excellent organizational and communication skills.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Quality Assurance

GDP Knowledge

Organizational Skills

Communication Skills

Educación

Bachelor’s degree in Pharmacy

STRA License

Descripción del empleo

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)