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