The Quality Manager is responsible for managing the Quality Department and monitoring and evaluating internal production processes, examining products to determine their quality, engaging with customers, and gathering product feedback, among other duties.

VDS Contract Manufacturing is a TGA Contract Manufacturing facility for listed medicine. As part of your role as Quality Manager you will also be appointed as an Authorised Person. The duties of an authorized person can be summarized as below:

a) An Authorised Person must ensure that each batch of medicinal products has been manufactured and checked in compliance with the laws in force in the country and in accordance with the requirements of the Marketing Authorisation;

b) The Authorised Person(s) must meet the qualification requirement laid down in the national legislation, they shall be permanently and continuously at the disposal of the holder of the Manufacturing Authorisation to carry out their responsibilities.

Core objectives include:

· To approve or reject, as he/she sees fit, starting materials, packaging materials, intermediate, bulk and finished products.

· To ensure that all necessary testing is carried out and the associated records evaluated.

· To approve specifications, sampling instructions, test methods and other Quality Control procedures.

· To approve and monitor any contract analysts.

· To ensure the qualification and maintenance of his/her department, premises, and equipment.

· To ensure that the appropriate validations are done.

· To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

· The authorisation of written procedures and other documents, including amendments.

· The monitoring and control of the manufacturing environment.

· Plant hygiene.

· Process validation.

· Training.

· The approval and monitoring of suppliers of materials.

· The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities.

· The designation and monitoring of storage conditions for materials and products.

· The retention of records.

· The monitoring of compliance with the requirements of Good Manufacturing Practice.

· The inspection, investigation, and taking of samples, to monitor factors which may affect product quality.

· Participation in management reviews of process performance, product quality and of the Pharmaceutical Quality System and advocating continual improvement.

The above list is not exhaustive, and the role may change to meet the overall objectives of the company.

Licences, registrations and qualifications

· Degree in business administration or relevant field.

· Quality control certification is advantageous.

· Open drivers licences

Experience

· At least five (5) years’ experience working in a GMP certified facility.

· Experience in working with the TGA, ACO and HACCP regulators.

Skills and competencies

· Excellent attention to detail

· Excellent verbal and written communication.

· Data analysis and statistical aptitude.

· Good interpersonal skills.

· Highly conscientious and diligent.

· Must be an Australian resident with full working rights.

This job description serves to illustrate the scope and responsibilities of the post and is not intended to be an exhaustive list of duties. You will be expected to perform other job-related tasks requested by management and as necessitated by the development of this role and the development of the business.