PT Cekindo Business International memberi kesempatan untuk bergabung bersama QA Manager (Pharmaceutical Manufacture) di Semarang Tengah, Jawa Tengah.
Deskripsi Pekerjaan
Currently, we’re looking for a Quality Assurance Manager position for our client, Singapore’s biggest manufacturer of generic pharmaceuticals that just established in Semarang, Indonesia.
Job Description:
Must be a Qualified Pharmacist. Manage the Quality Assurance (QA) activities in the manufacturing facility on a day-to-day basis to ensure compliance to GMP requirements and regulation.
- Set up and maintain the Quality Management System in accordance with GMP requirements, regulation and company policies.
- Ensure that quality practices and international standards such as GMP, GDP, ISO, PIC/S, etc. are adhered to.
- Set up and maintain the Quality Change Control System and ensure all the documentation are in a constant state of regulatory compliance and inspection readiness. 
- Ensure the authorisation of written procedures and other documents, including amendments are appropriate. 
- Set up and maintain all Quality Assurance (QA) activities in the manufacturing facility e.g. production, engineering & etc are in a constant state of regulatory compliance and inspection readiness. 
- Ensure the compliance of the monitoring and control of the manufacturing environment plant hygiene process validation, training approval of suppliers of materials approval of contract manufacturers and providers of other GMP related outsourced activities the designation of storage conditions for materials and products retention of records maintenance /calibration system compliance with requirements of GMP regular inspection, investigation and taking of samples for product quality monitoring and etc.
- Able to manage regulatory and customer audit and provide timely and accurate responses.
- To participate in management reviews of process performance, product quality and of Quality Management System and advocating continual improvement.
- Continually review and improve the Quality Assurance (QA) activities’ operational support and efficiency.
- Ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management.
- Performs any other related duties as assigned by immediate superior.
 
Requirements:
- Educational Background in Pharmacy and have active license.
- Prior experience of at least 5-7 years in Quality Assurance and/or minimum 3-5 years supervisory or managerial role preferred.
- Strong knowledge of GMP, GDP, ISO, PIC/S, and other relevant international standards.
- Effective management of QA activities in a manufacturing setting.
- Experience in managing regulatory and customer audits.
- Continuous improvement mindset.
- Fluent in English.
