Quality Operations Associate
4 weeks ago
**Quality Operations Associate**:
**Contract Type**:
- Permanent**Location**:
- Melbourne**Industry**:
**Contact Name**:
- Jennie Elkington-
**Contact Phone**:
- 0894682045**Date Published**:
- 06-Jun-2023**Quality Operations Associate**
**Permanent role**
**Claremont WA**
Our client is seeking a full-time Quality Operations Associate to support the continued growth of their innovative medical/health business, You will manage the day-to-day operational quality activities and initiatives and ensure the business fulfils the obligations as a sponsor of therapeutic goods.
Reporting to the Operations and Regulatory Manager, and working closely with the whole team, the Quality Operations Associate will drive operational quality activities through exceptional organisation, communication, and relationship management skills, evidenced by prior experience in Quality Management Systems or pharmaceutical production and distribution roles.
Leveraging a foundation in pharmaceutical production, regulatory affairs and/or medical sciences, you will build an in-depth knowledge of our client's range of medical products, and their customers and broader industry to ensure the technical and medicinal values of their products are maintained.
**Quality Operations (90%)**
- Assist with the implementation and maintenance of quality systems, policies and procedures.
- Ensure compliance of company operational activities with the quality management system and regulatory requirements by:
- reviewing and approving product specifications, batch release documentation and certificates of analysis;
- maintaining product registers;
- reviewing and approving product packaging and labelling artwork; and
- ensuring document records are developed and maintained to the required standard.
- Assist with the development and ongoing review of product specifications, product quality reports, and product stability data.
- Lead the qualification and assurance of current and potential service providers, including manufacturers, suppliers and third-party logistics providers.
- Undertake internal quality audits to identify strategies and process improvement opportunities to enhance product quality, organisational efficiency, and compliance.
**General Operations (10%)**
- Assist the sales team with review of advertising and promotional material against company internal guidelines and TGA standards.
- Assist the sales team with patient support tasks, including inbound enquiries, monitoring feedback and returns, and other ad-hoc tasks.
**Qualifications, Experience And Key Criteria**
***
- Education: Bachelor’s degree in supply chain management, commerce, engineering, law or another relevant field. Relevant post-graduate qualifications will be favourable.
- Experience: Strong understanding of quality systems and their requirements in pharmaceutical production and distribution. Experience with systems implementation. Working experience with Quality Systems.
- Qualifications: Comply with criminal record and drug screening as required. Excellent communication, both written and verbal. Exceptional attention to detail. Digitally enabled and comfortable with Microsoft 365 (Word, Excel, PowerPoint, SharePoint)
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