QA Manager
at Abbott Laboratories
Eastwood NSW 2122, New South Wales, Australia -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 07 Sep, 2024 | Not Specified | 08 Jun, 2024 | N/A | Good communication skills | No | No |
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Description:
We have an exciting opportunity for a Quality Assurance Manager for Abbott Medical, reporting to the Quality Director, ANZ.
PROFESSIONAL KNOWLEDGE, SKILLS & QUALIFICATIONS
Industry Experience
- Previous experience in a similar role within a medical device or pharmaceutical organisation is preferred
Qualifications
- Tertiary level qualifications in a technical/scientific or related discipline
Responsibilities:
ROLE SUMMARY:
- Manage and develop the local ANZ Quality System to ensure alignment and compliance to Abbott internal requirements.
- Manage and develop the ANZ Quality Management System to ensure ongoing ISO9001 certification.
- Manage and implement systems and process controls to ensure the appropriate storage, handling and distribution of Abbott Medical products.
- Audit support lead for external audits and Abbott Corporate Commercial audits.
- Effectively communicate a Quality focused mindset across the commercial organisation and champion quality initiatives for ANZ.
- Support Abbott Medical’s compliance to post market regulations from the Australian TGA and New Zealand Medsafe.
RESPONSIBILITIES
Manage and Develop ANZ Quality Management System
- Implement, maintain and develop the ANZ Quality Management System (QMS) and ensure alignment with the Global Commercial QMS (GCQ); the cross divisional One Abbott Commercial Affiliate (OACA); Abbott corporate quality (AQ) and local regulatory requirements
- Participate actively in the GCQ global projects and workstreams
- Focus on continuous improvement of quality processes and customer satisfaction and where appropriate update SOPs accordingly
- Manage documentation control
- Identify and investigate quality issues through the Customer Feedback/SCAR/CAPA processes, suggest and implement corrective actions.
- Propose preventive actions to avoid problems
- Maintain certification of the ANZ operation to ISO9001
- Conduct internal audits of the implementation of the quality system, facilitate corporate quality audits and quarterly management reviews with senior management
- Manage all quality system suppliers and distributors for evaluation, performance review and re-evaluation
- Ensure training of distributors/third party warehouses is completed on quality aspects described in their contract
- Participate in ship hold process and damaged or non-compliant product to ensure materials are quarantined and dispositioned appropriately
- Support post market regulatory compliance (as applicable) in areas such as adverse event reporting, post market reviews, annual reporting and field actions
- Coordinate non-product software and computer systems validation activities, as well as spreadsheet verifications/validations where required
Effectively communicate a Quality Mindset
- Effectively communicate a positive Quality focused mindset across the organisation making the QMS relevant to each role including key performance indicators
- Develop engaging training materials, ensure employees receive appropriate training assignments via established learning plans, and ensure the QMS is deployed consistently
Post Market Regulation Support (as required)
- Ensure field action team members are trained and understand their role and responsibilities in advance.
- Assist the QA Director to implement FSCA according to instructions provide
- Maintain records of all activities, tracking list, translated DDL, reconciliation reports, acknowledgment forms etc. and upload to Record Inventory Management System (RIMS)
- Support specific requests with regards to TGA Post Market Reviews (PMR)
- Coordinate and submit annual reports
- Submit Consent to Supply requests (if required) as part a field action
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Production / Maintenance / Quality
Software Testing, Clinical Pharmacy
Graduate
Proficient
1
Eastwood NSW 2122, Australia