Senior Specialist, QA System
6 months ago
Responsibilities:
• Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards
• Responsible for regulatory authority inspections and external customer audit management, including inspection preparation, establish inspection support team, CAPA response submission
• Supplier audit and qualification management, including supplier performance review, approved supplier list & approved material list management, supplier audit schedule development and audit implementation, quality agreement management
• Self-inspection management, including self-inspection plan development and implementation, follow up the execution of CAPAs to the observations in self-inspection
• Manage the quality review of plasma center, including the on-site audit of critical materials in plasma center
• CAPA management and eQMS management, oversight the whole CAPA process, monitoring the CAPA KPIs, make sure CAPA are managed in an efficiency way
• Regulation monitoring, organize, coordinate, and supervise the gap analysis against new and revised GMP regulations, ensure the implementation of the identified measures
• Product Quality Reviews (PQR) & Drug Annual Report management
• Ensures standard operating procedures (SOP’s) stay current and align with corporate and regulatory requirements
• Executes training/awareness related to GMP standards
Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
• Knowledge of current Good Manufacturing Practices (cGMP) principles
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you.
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