Quality Assurance/Regulatory Affairs Pharmacist

Job Responsibilities: Regulatory and Quality Assurance Related Activities: Management of Controlled Drug License related activities and document all transaction activities for traceability and audit purpose Oversee the ordering and distribution of quality controlled drug product and ensure the processes complied with the misuse of controlled drug act Tracks status of submissions pending at regulatory agencies as required Responds to internal/external customer regulatory requests Writes and assembles domestic regulatory submissions Various tracking, data entry assignments (related to Drug licenses) Perform Quality Assurance functions Implements department improvement projects Prepares, maintains and updates library or external regulatory standards, reference and guidance documents manage GDPMDS and GDP audits Manage special assess routes in medical device Any other general regulatory and quality activities or project been assigned by the supervisor Job Requirements: Licensed/Fully Registered Pharmacist At least 3-5 years of quality assurance working experience in pharmaceutical industry Working knowledge of GMP and GDP in the pharmaceutical industry