Quality Systems Officer

2 weeks ago

Perth, Western Australia Perrigo Company Full time

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.

We are looking for an experienced QA professional to join our Balcatta quality operations team. This role is responsible for the review of completed batch documents and performing batch release for supply and distribution, processing change controls in accordance with company policy, performing annual product reviews and assisting in the implementation of broad preventative actions and quality improvement programs. The incumbent must always promote a quality culture throughout the organisation and lead by example for all quality related activities.

**Duties**:

- Responsible for reviewing batch records to ensure compliance to required standards
- Review QC test records, microbial and sterility reports to ensure all results are within specification
- Reconcile any process or testing deviations and ensure they are closed out prior to release
- Interact with production and QC Staff to correct batch document issues
- Perform the release for supply / and or distribution
- Process batch documents on SAP
- Perform annual product reviews as per agreed schedule
- Administer & coordinate the change control system
- Coordination & facilitation of site-wide calibration & metrology program
- Coordination & facilitation of core GMP training modules
- Conduct Internal / External audits as requested
- Collect and collate data and documentation required to support the quality management system, including trend reporting.

**Skills & Experience**:

- Tertiary qualifications in Science, Pharmacy or Engineering
- A minimum of 5-7 years' experience in the Pharmaceutical Industry
- 3 Years' experience with quality management systems in a regulated manufacturing environment
- Specific understanding of the pharmaceutical industry and of regulatory compliance requirements.
- Excellent skills in organisation, planning and communication.
- Attention to detail and an ability to work autonomously
- Experience of QA / QC activities in GMP/GLP or similar environment.
- Effective general office and computer skills (Microsoft Word, Excel etc.)

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