Deskripsi Pekerjaan
Amarox Pharma Global is currently seeking a meticulous and experienced Quality Control Supervisor to join our expanding manufacturing facility in Cikarang Pusat. In this pivotal role, you will be the guardian of our product integrity, ensuring that every batch meets the highest standards of safety, efficacy, and quality. You will lead documentation systems, oversee compliance with GMP and ISO 9001 regulations, and act as a key liaison during internal and external audits.
We are looking for a proactive professional who thrives in a fast-paced manufacturing environment and possesses a sharp eye for detail. You will collaborate closely with cross-functional teams to resolve quality deviations, streamline processes, and ensure that our pharmaceutical products consistently exceed regulatory requirements. If you are passionate about quality excellence and want to drive operational standards in a global pharmaceutical company, we invite you to apply.
Tanggung Jawab
- Supervise daily QC operations to ensure strict adherence to GMP and ISO 9001 quality management systems.
- Manage and maintain comprehensive documentation systems, including SOPs, batch records, and quality manuals.
- Lead and support the preparation for local and international regulatory audits and inspections.
- Conduct thorough root cause analysis (RCA) for quality deviations and implement effective CAPA (Corrective and Preventive Actions).
- Collaborate with cross-functional departments (Production, R&D, Supply Chain) to facilitate smooth product registration and market release.
- Monitor testing protocols and ensure all analytical equipment is calibrated and maintained in compliance with global standards.
- Mentor and develop QC staff to foster a culture of quality awareness and continuous improvement.
Kualifikasi
- Bachelor’s degree in Pharmacy, Chemistry, Biology, or a related field.
- Minimum 3-5 years of experience in a Quality Control or Quality Assurance role within the pharmaceutical or chemical manufacturing industry.
- In-depth knowledge of GMP (Good Manufacturing Practice), ISO 9001, and local pharmaceutical regulatory requirements (BPOM).
- Proven experience in handling documentation for regulatory audits and product registrations.
- Strong analytical, troubleshooting, and decision-making skills.
- Excellent communication and leadership abilities to drive quality culture across different levels of the organization.
- Proficient in MS Office suite and Laboratory Information Management Systems (LIMS).