Regulatory Affairs and Quality Manager
Salary: Competitive and based on experience
Location: South Jakarta
Keywords: Regulatory Affairs, Quality Assurance, Manager, Pharmaceuticals, Medical Devices, Supply Division
Our client is seeking a dedicated Regulatory Affairs & Quality Manager to join their team in South Jakarta. This role is pivotal in maintaining the highest standards of quality and regulatory compliance within the Supply Division, serving several industries sectors. The successful candidate will be instrumental in saving lives and improving health in remote corners of the world by ensuring the right medical supplies are available when and where they are needed.
- Key role in maintaining regulatory licenses for business operations.
- Responsible for product registrations for importation and wholesale.
- Supports quality agenda and upkeeps Supply Division quality management system.
What you'll do:
As an Regulatory Affairs & Quality Manager, your role will be multifaceted. You will act as the Responsible Pharmacist/Technical Person to perform Regulatory Functions. Your responsibilities will include maintaining Good Distribution Practices Certification (CDOB) following local regulations. You will also lead and support all regulatory aspects for the Supply Division. Additionally, you will develop, implement, and maintain SOPs on Quality Management Systems. Training staff on these systems will also fall under your purview. You will handle change controls, quality-related events (deviations), investigate them thoroughly, and take appropriate Corrective and Preventive Actions (CAPA). Achieving business-relevant certifications will be a key part of your role.
- Act as the Responsible Pharmacist /Technical Person to perform Regulatory Functions.
- Maintain Good Distribution Practices Certification (CDOB) following local regulations.
- Lead and support all regulatory aspects, issues for Supply Division.
- Develop, implement and maintain SOPs on Quality Management Systems.
- Train staff/stakeholders on Quality Management Systems and maintain records.
- Perform supplier, product and customer qualifications in line with corporate Quality and local regulations.
- Handle change controls, quality related events (deviations), investigate and take appropriate Corrective and Preventive Actions (CAPA).
- Achieve business relevant Certifications.
What you bring:
As an Regulatory Affairs & Quality Manager, you bring a wealth of knowledge and experience to the table. You are a qualified licensed/registered pharmacist in Indonesia with a Bachelor's Degree in Pharmacy or Life Sciences. You have a good understanding of structuring and maintenance of ERP product master. Your ability to write procedures, conduct audits, and handle other quality-related tasks is exceptional. You are adept at planning and organizing, setting clearly defined objectives, planning activities well in advance, and managing time effectively.
- Qualified as a licensed / registered pharmacist in Indonesia.
- Bachelor Degree in Pharmacy or Life sciences.
- Knowledge of structuring and maintenance of ERP product master.
- Skills to write procedures, conduct audit and other quality related tasks.
- Planning & organizing skills: Sets clearly defined objectives; Plans activities well in advance; Manages time effectively.
What sets this company apart:
Our client is a global leader in providing medical supplies to the remotest corners of the world. They are dedicated to saving lives and improving health across various sectors including aviation, yachting, maritime, oil and gas, government and NGOs, energy, mining, and infrastructure. Their commitment to quality and regulatory compliance sets them apart from others in the industry.
What's next:
Ready to make a significant impact on global health? Apply now!
Apply today by clicking on the link provided. Please note that only shortlisted candidates will be contacted.
Due to the high volume of applications we are experiencing, our team will only be in touch with you if your application is shortlisted.
