Interview P2 - Development & Improvement Flashcards

1
Q

What was your growth the last 3 years, wat insights have you gained?

A

“o The transformation from GMP-specialist within the IPT, to the manager of a large team within QR. Growth into management and a paradigm shift in what the organization needs.
o Motivate: not everybody is intrinsically result driven or has the same level of dedication for the company. Within QR we have no limiting equipment, it is the people that make the difference between limitations or opportunities. Empowering employees, by giving them responsibilities coupled with focus and positive feedback, can grow a team to be proud of our work. Examples: focus on MBTR, cross-training tell what is decided (one person will cross train CoA) and give team room to fill that framework, when moved to 020 get the team to decide who sits where.
o Form a team: (from different sub-teams) Cross-training, go-see colleagues, discuss process when teammember also does steps. Elimination of 3th checks, process optimizations like NCOA flag by review operators (not QA-NPC).”

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2
Q

Strength and weekness?

A
"S1 = Calm logical thinker
S2 = Reliable, objective, consistent
S3 = Result oriented, Practical minded
W1 = Proactive positive communication. Empathical coaching (how did it feel?)"
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3
Q

What is your biggest development point as a manager? Approach?

A

Experience in strategic projects, but less in site strategy, how do we do it compared to other sites. Pro-active communication. Tier1, mindset seeking profit, instead of Lean SS problem find and solve mindset.

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4
Q

What is your biggest development point as a specialist? Approach?

A

“Limited MSD QP experience
S: As hospital Pharm. had responsibility for release
T: from GMP studymedication to GMPz patient preparations and oncology/radiotherapy.
A: Have done the release for several years, have the background knowledge, I know the responsibility know how it feels.
R: I have release experience, I have knowledge of the release process at MSD, I’m halfway with the MSD QP training program and already on the MSD permit as QP.”

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5
Q

What’s nice about being a specialist?

A

“I think production of gnm is cool.
S: RJ recently gave a presentation about the production process of Vaqta (Baxter/Parkway)
T: I was there because project Parkway provides some tasks (different EBR registration process) for my team.
A: I get really excited about these kinds of presentations, I want to know more and ask questions. (Is it a class A aseptic manufacturing process with class C background space?)
R: Getting data about the production process is completely in line with my interests and my preferred blue style.”

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6
Q

What do you like about being a manager?

A

When I can help a team member as a coach. Stefke coaching from contingency to SME to QROLv2.

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7
Q

How apply your BL knowledge? / How do you see the collab?

A

I will be able to quickly get up-to-speed and collaborate with the IPT lead, as I speak the same language and understand the quality challenges on BL. With years hands-on experience on IPT BL and being result driven, it will give me the confidence to decide in gray areas and support QSIP implementation discussions.

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8
Q

What is the cascade when your M1 position comes open?

A

“My view is that a M1 with strong p.manag. and quality mindset is key. Our site has lots of willing and competent people:
A) I know people within QR, both QP’s (e.g. Pepijn, Richard) and QROlv2 (e.g. Stefke). [Roulation if from own team]
B) There are also several IPT PS that will be interested (e.g. Renske Bos, perhaps Anton/Marko/Sofie) or other IPT Specialist (e.g. Matthijs Kooij, Jorrit Sijtema)
C) There may be coaches from IPTs or the lab with interest, especially if an assignment 1-2 years is possible
And there may be many pharmacists working in MMD, GHH, MRL with the right competencies.”

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9
Q

Your focus, what to improve? Future proof oppertunities you Q-Lead BL?

A

“ROT & Q-support:
A) As BL FiGo is Short-leadtime high-throughput, it is always an opportunity to collaborate on the ROT/MBTR with IPT lead (Caroline P.) and SCM (Ernst H.) + SME level (e.g. PS/QP collab. Dev.Red.). Specific topics can be MDMA testing on-site (to reduce the leadtime) and Janumet Singapore bulk release.
B) Another opportunity is the support of Quality in enhancing the BL portfolio: new prod. Launches as Gefapixant for Chronic Coach, tech.transf. perhaps Januvia from Organon. PIR to keep Q-reputation high for Organon. So to prioritize activities not only on urgency but also on added value for the near future: I currently work on a HC-CM to make this possible.”

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