Quality Assurance (Qa) Manager

On behalf of our client, a new pharmacy company located in Semarang. we are currently seeking an experienced Quality Assurance (QA) Manager.
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.
• 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.