Job Purpose
To monitor and ensure that all pharmaceutical products are safe and manufactured in compliance with Good Manufacturing Practice and distributed according to Good Distribution Practice and other relevant GxPs to ensure achievement of corporate goals.
Qualifications and Experience
- Graduate of Bachelor of Science in Pharmacy is a must
- Licensed by Professional Regulation Commission
- With at least one year Quality Assurance experience in a local or multinational pharmaceutical company
Major Accountabilities
- Monitor and follows through on quality initiatives.
- Monitor and implement programs to improve quality.
- Provide management information on quality related matters
- Review change controls for all level of manufacturing change/s
- Ensures that product and process deviations, out-of-specifications (OOS), complaints, and recalls are reported, investigated, resolved, and documented properly
- Check and ensure all locally and internationally manufactured products meets the required specification set prior release in the market
- Review all technical reports from local toll manufacturer
- Monitors Quality Agreements with third party distributors and suppliers
- Assist in the Audits of third party distributors and suppliers, ensuring adherence to GMP / GDP, QMS, and regulatory requirements
- Assess annual product reviews submitted by 3P manufacturers and to report results
- Coordinate with distributor (ZPC and others if applicable) with regard to products for redressing and/or repackaging
- Conducts inspection of damage stocks at distributors warehouse
- Assess and propose disposition for product returns.
- Ensures that damaged and expired materials are properly destroyed
- Check the quality of packaging materials, from artwork development up to the finished product
- Checks the quality of promotional and non-promotional materials
- Review and secure approval on changes with impact on quality, safety, and registration status of products prior to implementation
- Ensures proper documentation and archiving of QMS documents, along with maintaining traceability
- Performs other tasks and duties which may be assigned by the immediate supervisor from time to time
