Senior QA Specialist

at  Abbott Laboratories

ABOUT THE OPPORTUNITY:

The incumbent will actively support the quality efforts of Australia & New Zealand as part of the organization’s business objectives, reporting directly to the in-country Quality Manager. The role is responsible for the management and monitoring of critical quality process performance acting from a subject matter expert perspective, ensuring continued compliance to internal quality requirements and standard. This will be achieved thought compliance to internal procedural requirements, and the development and implementation of additional SOPs, work instructions, checklist etc., where applicable. This role is responsible for the monitoring of compliance, the communication of procedural requirements, training on quality system requirements and supporting corrective actions where applicable.

REQUIRED EXPERIENCE AND BACKGROUND:

• 3+ years in a QA Role within the Medical device, Pharmaceutical or related industry experience.
• Experience in the handling of adverse event for reporting purposes and corrective & preventative action problem-solving methodologies, including root cause analysis.
• Ability to develop procedures and policies that clearly define efficient processes needed to ensure compliance and resolve identified problem.
• Experience in document control & training management.
• Knowledge of change management & risk assessment and ISO 9001 is preferred.
• Experience in leading and participating in cross-functional teams tasked with QA problem resolution.
• Experience in training curriculum development and external supplier quality management is preferred.
• Knowledge of internal audit program management.
• Proficiency in Microsoft Office software (i.e., Word, Excel, and PowerPoint).

• Play a major role in the facilitation of the communication of adverse events to the Regulator.
• When quality gaps are identified, and Corrective and Preventive Actions (CAPA) are required, lead investigations & root cause analysis, supporting the development & implementation of appropriate corrective actions.
• Act as the main Document control and training admin for the local quality system.
• Support the evaluation & quality management of internal & external suppliers. Assist QA Manager ANZ to manage the internal auditing program.
• Play a major role in the tracking and trending of quality departmental key performance indicators, to allow efficient oversight of the local quality system.
• Establish effective partnerships within the business locations to ensure QA needs are identified and successfully met.
• Build effective relationships with local departmental representatives, Regulatory body representative & Global counterparts.