THE ROLE, COMPANY & LOCATION:
A fantastic opportunity has just opened for an QA officer to join a global Pharmaceutical organisation on a full time basis. You will be responsible for maintaining TGA accreditation. The company is located in the Southern Brisbane / Northern Gold Coast
- Strong QC/QA experience in TGA environment is highly recommended to apply
- State of the art equipment
- Be part of a brand new start-up company
- Opportunity to progress within a global organisation
JOB SPECIFIC DUTIES INCLUDE:
- Maintain all official manufacturing documentation, SOPs, specifications, master batch records, quality control documentation, and validation packages
- Ensure Good Manufacturing Practices (GMP)
- Validation of equipment (eg Fermenters, Tanks and Ovens)
- Support and preparation of documentation for customer and regulatory audits
- Issue batch lot numbers for various drug and medical device products.
- Review, release, and reconcile printed materials (labels and unit carton) for accuracy.
- Managing internal / TGA auditing processes and ensuring compliance is met
- Supporting customers directly with regulatory, product or quality enquiries and providing appropriate advice
- Involvement with and support of other aspects of the quality management systems, e.g. validation, customer complaints, reworks, etc.
- Degree in Science, relevant Scientific discipline or extensive QC experience in a TGA environment
- Minimum 1-2 years' experience in a cGMP or TGA operational environment
- API experince
- Regulatory experince is highly regarded
- Suitable candidates will need to be flexible with day, afternoon and night shifts
HOW TO APPLY:
Please apply with an updated CV or for more information, contact Victoria Chin or Melissa Kennedy on (07) 3343 6777. Alternatively, you can email firstname.lastname@example.org.