My most recent role was on the extended leadership team of the Sydney based manufacturing operations of Pfizer Australia with responsibilities for the following:• Leading, developing and cultural engagement of a team of up to 13 direct reports• Driving a science and risk based Lean culture focused on continuous improvement• Core member of the site quality review team responsible for key quality related decisions for the site• Ensuring adherence to product registrations with Regulatory Authorities• Strategy development for the site and roll out of initiatives to deliver on targets• Presenting to senior leaders on Laboratory and Quality Operations achievements and focus areas for quarterly operational meetings• Maintaining a culture of quality and compliance by ensuring high GMP and GLP standards• Application of six sigma principles to solve analytical problems and evaluate changes in manufacturing processes• Ensuring key quality metrics are monitored and met• Building an environment where direct reports objectives and development plans are aligned with business needsAchievements:• Development and implementation of a new training system for the laboratory• Roll out of Lean Labs in the Operations Laboratory, leading to increased throughput and reduction in human error etc.• Supporting audits from Regulatory Authorities to maintain reputation for high quality manufacture• Ensuring the site had a 99% average in stock performance (best in class in Pfizer network)• As part of the extended leadership team I played an integral role in supporting the organisation through a major change to cease manufacturing in Sydney• Led the transfer of all retention samples globally to 7 different Pfizer/non-Pfizer sites• Roll out of a data integrity program in the laboratory incorporating assessment & remediation plans which ensured no data integrity findings from TGA in most recent audit• Utilisation of quality risk management tools to challenge and improve processes

Reporting to the Quality Control Manager, I worked for 10 months as an analyst with the responsibility for the analysis of raw materials and finished products in a TGA and GMP compliant environment. I then progressed to the role of Senior Analyst and had the responsibility for the following:• Scheduling of work within the laboratory to meet customer demands• Laboratory data review & approval of raw material, finished product for release & stability results• Lead investigations in a timely manner to determine root cause & implement CAPAs• Supporting analysts in troubleshooting and problem solving• Review and update of relevant technical documents and procedures• Analytical data trending to identify out of trend results• Ensure compliance with local/global Pfizer policies and government regulations in relation to quality (TGA and PIC/S Code)Achievements:• Maintained customer satisfaction by making timely, quality and effective decisions• 99% on time closure rate for QC related investigations, change requests & action items• Developed & implemented visual management tools for daily team management

Reporting to the Technical Services Leader I worked in a highly quality oriented environment. The position involved providing analytical support for both the Technical Services and Quality Control functions. I worked with new teams and quickly formed relationships with colleagues and customers.Achievements:• Development of a UPLC cleaning method for the highest volume product on site to reduce analysis times• In response to an Irish Medicines Board (IMB) query for a major product, I worked with the global analytical team within a small timeframe to develop and implement an analytical method for the assay of an enzyme used in the manufacturing process

Reporting to the QC Supervisors, I was responsible for the sampling and analysis of raw materials, intermediates and APIs. Achievements:• I was recognised for my flexibility & ability to prioritise daily workload to meet customer demands.