Alamat
Bentuk pekerjaanOn behalf of our client, a new pharmacy company located in Semarang. we are currently seeking an experienced Quality Control (QC) Manager.
Job Description:
Must be a Qualified Pharmacist. Manage the Quality Control (QC) activities in the manufacturing facility on a day-to-day basis to ensure compliance to GMP requirements and regulation.
- Set up and maintain the QC Laboratory (including Microbiological Laboratory) 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 all Quality Control (QC) activities are in a constant state of regulatory compliance and inspection readiness.
- Ensure the compliance of the monitoring and control of approval or reject of starting material, packaging materials, intermediates, bulk and finished products; all necessary testing is carried out and associated records evaluated; to approve specifications, sampling instructions, test methods and other Quality Control procedures; approve any contract analysis; qualification & maintenances in QC premises & instruments; appropriate validations are performed; required initial and continuing training of his department personnel is performed and adapted when necessary.
- Able to manage regulatory and customer audit and provide timely and accurate responses.
- Set up and maintain the QC Laboratory and ensure all the documentation are in a constant state of regulatory compliance and inspection readiness.
- 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 Control (QC) 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 5 to 7 years in Quality Control Laboratory and/or minimum 3 -5 years supervisory or managerial role preferred.
- Strong understanding of GMP requirements, international standards, and regulatory compliance.
- Supervisory or managerial experience in a Quality Control Laboratory setting.
- Ability to manage audits and provide timely responses.
- Excellent communication and documentation skills.
- Proven experience in process improvement and advocating for continual improvement.
- Independent worker with a high level of responsibility.
- Must be able to work independently.
- Fluent in English.
