Quality System Specialist (Pharmacist)
Detail posisi
Kewajiban
• Work with all departments in implementing and complying with Quality Systems and cGMP requirements.
• Execute the activities of sections or with responsibility for results in terms of product safety, quality, and efficacy.
• Review production batch record and analytical results preparing for release for sale.
• Involve/support team for investigation of any problems related to product safety, quality, and efficacy.
• Support necessary training or coach team for any quality issue.
• Handling of product complaint/FCA’s.
• Coordinate with the customer and team for investigation for product complaint.
• Responsible to follow up the corrective and preventive action of product complaint issue.
• Evaluate new suppliers and maintain existing suppliers.
• Coordinate between supplier and team for supplier corrective actions.
• Conduct supplier audit for new supplier evaluation and maintain existing suppliers.
• Handling of internal and external audits.
• Documentation control.
• Manage and control training in BAXU system.
Kualifikasi
• Bachelor of Pharmaceutical with Pharmacy License.
• At least 2 years of experience in Quality system or manufacturing in a Pharmaceutical or Medical Device Company or regulated industry.
• Having knowledge in GMP, PIC/S., or ISO9001.
• Ability to interface with all levels of employees, supervisory & management.
• Strong communication and people skills.
• Knowledge of GMP for medical/ pharmaceutical manufacturing environment.
• Good command of English and Computer literacy.
• Strong analytical and problem-solving skills.