Branch Regulatory Quality Assurance

PT Anugerah Pharmindo Lestari; Danauindah; On-site; IDR 167,400,000 - 234,360,000; Full time

Job summary

PT Anugerah Pharmindo Lestari (APL), a Zuellig Pharma company, seeks a Branch Regulatory Quality Assurance professional in Indonesia to safeguard product quality and compliance across the distribution process.

You will lead audits, CAPAs, and training, ensuring SOPs align with CDOB/CDKAB standards and ready the branch for inspections.

Qualifications

• Bachelor’s degree in pharmacy is required.
• Registered Pharmacist with STRA is required.
• Strong communication and interpersonal skills; ability to influence stakeholders at all levels.

Responsibilities

• Monitor and oversee daily distribution activities at branch to ensure compliance with CDOB and CDAKB.
• Ensure adherence to internal SOPs, policies, and procedures per regulatory requirements.
• Conduct regular internal audits, self-inspections, and compliance assessments to identify gaps and risks.
• Coordinate CAPA for non-conformities identified during audits or inspections.
• Ensure proper documentation and traceability of distribution processes per standards.
• Support branch readiness for regulatory inspections and act as primary liaison during such activities.
• Provide training and awareness on regulatory compliance and quality standards to branch personnel.
• Monitor regulatory changes and implement updates at the branch level.

Skills

Communication skills

Interpersonal skills

Stakeholder influence

Education

Bachelor’s degree in pharmacy

Registered Pharmacist with STRA

Job description

PT Anugerah Pharmindo Lestari (APL) a Zuellig Pharma company, is a leading healthcare solutions in Indonesia, and our purpose is to make healthcare more accessible to the communities we serve.

We provide world-class distribution, commercialization, and clinical trial support to support the growing healthcare needs in this region. The company was started forty years ago and has grown to become a billion-dollar business covering 514 cities with over 2,500 employees.

Our people serve more than 60,000 direct and indirect medical facilities and work with over 50 clients, including the top 20 pharmaceutical companies in the world.

Purpose Of The Role

The purpose of the Branch Regulatory Quality Assurance role is to ensure that all activities at NDC are consistently conducted in compliance with applicable regulatory requirements as well as internal quality standards.

This role is responsible for maintaining regulatory compliance, safeguarding product quality and safety throughout the distribution process, and supporting operational excellence by ensuring effective implementation of quality systems at the branch level.

What You’ll Do

• Monitoring and overseeing daily distribution activities at the branch level to ensure full compliance with CDOB (Cara Distribusi Obat yang Baik) and CDAKB (Cara Distribusi Alat Kesehatan yang Baik).
• Ensuring the implementation and adherence to internal SOPs, policies, and procedures in line with applicable regulatory requirements.
• Conducting regular internal audits, self-inspections, and compliance assessments to identify gaps, risks, and areas for improvement.
• Coordinating corrective and preventive actions (CAPA) for any non-conformities identified during audits, inspections, or operational activities.
• Ensuring proper documentation, record-keeping, and traceability of distribution processes in accordance with regulatory standards.
• Supporting branch readiness for regulatory inspections or audits conducted by authorities and acting as the primary liaison during such activities.
• Providing guidance, training, and awareness to branch personnel regarding regulatory compliance, quality standards, and best practices.
• Monitoring updates to relevant regulations and ensuring timely implementation of any regulatory changes at the branch level.

Must Have

What Will Make You Successful :

• Bachelor’s degree in pharmacy and Registered Pharmacist (with available STRA)
• Minimum 1 year experience, fresh graduates are welcome to apply
• Strong communication and interpersonal skills, with the ability to influence and build relationships with stakeholders at all levels.

Advantage To Have

• Understand GSDP for Pharma and Medical device (CDOB & CDAKB) are advantageous
• Understanding of supply chain logistics and warehousing best practices

Why Join APL

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect

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