AddressThe Senior Quality Officer will be responsible for ensuring all regulatory compliance (Food and TGA) is taken care of from raw material and packaging requirements through to final product specification. This includes monitoring and evaluating internal production processes, examining products to determine their quality, engaging with customers, and gathering product feedback, among other duties.
The Senior Quality Officer will report directly to the Quality Manager and assist all other members in the team to share skills and knowledge to ensure the company provides a final product of the highest standards
VDS Contract Manufacturing is a TGA Contract Manufacturing facility for listed medicine. As part of your role as Senior Quality Officer the duties is summarised below:
Responsibilities and Duties:
- Monitor compliance with the requirements of Good Manufacturing Practice for the manufacturing of TGA/Food products.
- Required to stay up to date with TGA and Food requirement and changes.
- Oversee the quality associates and delegates tasks are undertaken.
- Ensure daily audits are undertaken effectively.
- Approve and monitor suppliers for starting material received.
- Approve and monitor any other contract parties.
- Approve or reject, as he/she sees fit, TGA/Food starting materials, packaging materials, intermediate, bulk and finished products.
- Create raw material and finished product TGA/Food specifications, sampling instructions, test methods and other Quality Control procedures.
- Ensure that all necessary testing is carried out for TGA/Food purposes, and the associated records evaluated.
- Ensure sampling gets done in accordance with approved procedures.
- Ensure the testing of all starting material as well as testing of finished products to comply with regulatory standards.
- Ensure that the appropriate validations are done for TGA purposes.
- Create and review written procedures and other documents, including amendments.
- Monitor and control of the manufacturing environment.
- Monitor production plant hygiene is adhered to.
- Train staff in quality procedures.
- Ensure monitoring of storage conditions for materials and products is undertaken.
- Ensure retention and reference samples are recorded.
- Ensure the inspection, investigation, and taking of samples is performed to monitor factors which may affect product quality.
- Ensure the participation in reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement.
- Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
- Ensure in process controls, including those made in the production area by production personnel, are recorded.
- Ensure a suitable program is in place to record stability control data for all products when required.
- Ensure complaints, CAPA, risk assessment, deviations, non-conformance, change control, GMP agreement are actioned and recorded in a timely manner.
Senior Quality Officer Requirements:
- Degree in appropriate or relevant field.
- Quality control certification or similar experience is advantageous.
- Excellent attention to detail.
- Excellent verbal and written communication.
- Data analysis and statistical aptitude.
- Good interpersonal skills.
- Highly conscientious and diligent.
