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Team Member Spotlight: Rusli Kartadinata, Associate Quality Manager, Asia Pacific
Here at West, we are working by the side of our patients and customers to help contribute to a healthier world. Meet one of our team members, Rusli Kartadinata, and read his story to learn how he grew in his career at West from a Production Engineer to his current role as the Associate Quality Manager across Asia Pacific.
Tell us about your current role at West
I currently work as a Regional Quality Associate Manager in Asia Pacific. I support regional quality projects, technology transfers as well as China DMF (Drug Master File) submissions with two members on my team.
Can you share some background on your career path at West to date?
I’ve experienced an interesting nine years at West. I joined West in 2011 as a Production Engineer in the Operations department, where I was responsible for the Finishing and Metal production area, and then moved to the molding and trimming production area as a Senior Production Engineer. In 2017, I moved to Quality and took the role of Associate Quality Control Manager, where I was able to develop different skills such as Lean Six Sigma and ISO 9001 auditor. West provided me many useful training courses such as Leading Others, Leadership and People Management to help me grow from an individual contributor to a manager. Most recently, I have been promoted to my current role, Associate Quality Manager, supporting our Asia Pacific region.
What drives you to keep pursuing more opportunities, and do you feel well supported by West in your pursuit?
I’m a firm believer in a lifelong journey of learning. Thanks to the variety of roles I’ve held, as well as opportunities such as projects, mentoring and training courses given by West, I’ve enjoyed fruitful growth for my career and will keep working hard and continuously learning.
What do you like most about working for West?
West is a global company with people coming from different backgrounds, enabling me to have a different perspective on daily work, and providing the opportunity to learn more about different cultures across the world.
When you think about our mission to improve patient lives around the world, how do you think you help accomplish that mission within your role?
As One West Team, we come together to deliver for our customers and help them address their challenges. Most importantly, when we work as a team, everyone has the same mindset to achieve the best outcome, and most importantly, to improve patients’ lives.
To learn more about working at West, visit our Careers page.
<em>Summary of FDA’s recent Inspection for visible particles draft guidance “Inspection of Injectable Products for Visible Particulates” and how it applies to components</em><br />The visual inspection of injectable drug product has been a regulatory requirement since 1936<sup>1</sup>, however, successful implementation of the standard has been challenging for many organizations. The number of recall notices issued by the U.S. Food and Drug Administration (FDA) from 2010 through 2019 for injectable products due to visible particulate have reduced since 2014 but at the current trend, will be some time before it approaches zero<sup>2</sup>. Between 2009 and 2019, the presence of visible particles in parenteral product was the second leading cause for product recalls.<sup>3</sup> Patient safety is the main driver for requiring injectable products to meet the criteria of “essentially free of visible particulates.”<sup>4</sup>
During the 14 June 2022 Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Health Council concerns were raised regarding the challenges facing the implementation of Regulation (EU) 2017/745 (the Medical Device Regulation (MDR)) and the potential impact to the continued availability of certain medical devices on the EU market. Subsequently, at the 9 December 2022 EPSCO Health Council-<sup>1</sup>, the European Health Commissioner, Stella Kyriakides, proposed an urgent, targeted legislative initiative to amend the transitional provisions provided for in Article 120 of the MDR<sup>2</sup>.
In order to ensure the best quality drug product and optimal patient outcomes, it’s important for drug manufacturers to foster a collaborative effort with their packaging suppliers from the beginning – and that means starting with the patient in mind. Understanding patient needs and how that drug will be delivered, whether through one of West’s delivery devices or some other device, will help determine the needs within the West manufacturing process.
Most physicians agree - of all the services that can be performed for patients, eliminating the pain and fear of injections is at the top of the list. How can pain be minimized? One approach is to maximize syringe performance - whether the syringe is employed by a clinician, in an autoinjector, or in a wearable device. A critical element of syringe performance is the break-loose force. This is the force needed to overcome the plunger inertia in a filled syringe to initiate plunger movement and introduction of drug product. A lower, more consistent, break-loose force can provide for increased patient comfort.
<p><em>Teams Place 15 and 28 out of 120 Teams</em></p><p>The West DragonPhyre and DragonPhlame teams placed 15<sup>th</sup> and 28<sup>th</sup>, respectively, out of the 120 teams competing at the 11<sup>th</sup> Annual Philadelphia Dragonboat Festival on October 6, 2012.</p>