THE ROLE, COMPANY & LOCATION:
A fantastic opportunity has just opened for an experienced QA officer to join a global Pharmaceutical organisation on a full time, permanent basis. You will be responsible for batch release and supporting all the Pharmaceutical Quality Systems (PQS) to maintain TGA GMP accreditation. The company is located in the North-Eastern suburbs of Brisbane, an easy 11 minute commute to the CBD.
- $70 000 + Super
- Metropolitan Brisbane Location
- Opportunity to progress within a Global organisation
JOB SPECIFIC DUTIES INCLUDE:
- Maintenance and issue of SOPs, specifications, master batch records, Pronto (ERP) codes and BOMs, and related documentation
- Assist in the daily maintenance of GMP in the plant
- NCR's, deviations, change controls related to batches and materials
- Environmental monitoring and calibration management
- Managing the Stability, Product Quality Review (PQR) and internal audit systems
- Supporting customers directly with regulatory, product or quality enquiries and providing appropriate advice
- Working closely with solid dose R&D (Shanghai office) and Sales to delivery new solid dose products for Australian and export markets
- Approval of master labelling
- Maintaining and reporting KPIs for presentation at PQS meetings and other forums
- Involvement with and support of other aspects of the quality management systems, e.g. validation, customer complaints, reworks, etc.
- Degree in Science or related Scientific discipline
- Minimum 5 years' experience in a cGMP operational environment
- Experience with MRP systems highly preferred
HOW TO APPLY:
Please apply with an updated CV or for more information, contact Sibel Dincer or Melissa Kennedy on (07) 3343 6777. Alternatively, you can email firstname.lastname@example.org.