QA Manager

PT Mundipharma Healthcare Indonesia; Jakarta Pusat; On-site; IDR 167,400,000 - 279,000,000; Full time

Job summary

Mundipharma is seeking a Quality Assurance specialist for a fixed-term contract in Jakarta. The candidate will ensure product quality and regulatory compliance across the lifecycle, including complaint handling, release oversight, and recalls coordination.

Required are a Pharmacy degree and an active STRA license, with proven QA experience in the pharmaceutical sector and a strong emphasis on GDP compliance, documentation, and traceability.

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 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.

Skills

Organizational skills

Communication skills

Attention to detail

Compliance mindset

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)

Mundipharma is a global healthcare company with a presence across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East. Mundipharma is dedicated to bringing innovative treatments to patients in the areas of Pain Management, Infectious Disease and Consumer Healthcare as well as other severe and debilitating disease areas. Our guiding principles, centered around Integrity and Patient-Centricity, are at the heart of everything we do.

For more information visit www.mundipharma.com. For more information about Mundipharma's guiding principles and commitment to diversity and inclusion visit: www.mundipharma.com/people