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Inspection Process Owner - 12 month FTC

Job Summary:

The inspection Process Owner role is a new role in a newly forming team requiring in-depth technical and operational knowledge of inspection processes including automated, semi-automated and manual visual inspection.   Supporting key areas of the business, Process Owner will direct initiatives that improve the reliability and efficiency of manufacturing processes in addition to day-to-day support related to unplanned event troubleshooting, investigations, and implementation of CAPAs.

This is an onsite role Monday to Friday typically operating between 8am to 5:30pm with some flexibility and a requirement to work extended hours from time to time depending on manufacturing activities.

Primary responsibilities:

• Supporting inspection in delivering supply to patients by owning the assigned process and thorough understanding of all interfaces. This will include in-depth knowledge of the process, making sure that procedures, training plans and batch records clearly and correctly direct the process. 

• Proactive approach to safety, quality and compliance and actively seek opportunities to prevent events occurring.

• Gatekeeper (develop, review and update) of process documentation to maintain structure and control over generation and revision.

• Supporting investigations that impact on safety, product quality and/or compliance from a technical standpoint on the process ensuring thorough investigations are carried out.

• Utilises significant subject matter expertise to support or lead projects relating to continuous improvements and investigations within assigned area of responsibility. This relates to support for investigations (RCAs), CAPAs, change controls, training, improvement projects and audit support

• Ownership and project management of safety and quality related CAPAs to make sure that the right measures are identified and implemented to prevent future reoccurrence.

• Engaging with staff members within the inspection area to ensure technical understanding of the processes.

• Involved in the daily business management systems and reporting, have a clear understanding of what is happening in the assigned area of responsibility. Monitor any process trends, including business performance metrics. Identify actions that will enable the process and the Inspection areas better achieve and surpass metrics in the future.

• Provide technical input to the shifts on challenges that are encountered. Actively looking at ways to assist in the running of the business and provide support to actions that are related to assigned area of responsibility.

• Providing expertise to ensure that new products and projects are implemented in the inspection area are completed successfully.

• Effectively engaging and participating within a Lean culture environment where continuous improvement behaviours are expected, and programs are employed. The role will require incorporation of Lean concepts into assigned project(s). Managing and implementing projects that develop lean practices in the inspection areas.

• Providing input to strategic initiatives that will improve and develop inspection for the future. The Inspection Process Owner will then support any projects identified and will be a project manager on some initiatives. They will make sure that project timelines are met, challenges identified, and mitigations are in place and provide high level of communication and visibility on any projects that they own.

Knowledge/Skills:

• Problem solving skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity.

• Project Management and organizational skills, including ability to follow assignments through to completion.

• Demonstrated ability to work independently and deliver right first-time results under minimal direction.

• Escalate issues professionally and in a timely manner.

• Negotiation and Influence skills.

• Take initiative to identify and drive improvements using lean six sigma tools.

• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills.

• Decision Making skills and confidence to challenge others on decisions that impact the inspection area.

• Teamwork and coaching others.

• Ensures compliance within regulatory environment and ensures aseptic compliance throughout every project

• Familiar with data analytics.

Relevant Experience:

• Bachelor’s degree in a Science or Engineering discipline.

• 5+ years of biopharmaceutical GMP manufacturing experience in the pharmaceutical or medical device industry.

• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.