Interview P3 - Leadership & Batch Release Flashcards
What is your management style?
“Situational leadership: managing, coaching, leader and entrepreneur.
S1: Esther metric discussion
S2: Sherany Dealing MCM Initials”
Example of a difficult management situation?
Collaboration and interaction: Petra-Alex cooperation good
When was the last time you were angry?
I don’t get angry easily, I want give feedback before that point. Esther metric discussion
When was the last time you were proud?
When I can help a team member as a coach. Stefke coaching from contingency to SME to QROLv2.
What is the greatest achievement you have achieved in your current role?
At MSD LC-Project site wide award / At QR team collaboration (cross-training, brainstorming / thinking along with each other) [also projects like new Chopper and HC-CM]
You have limited QP experience, isn’t that difficult?
“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.”
What were you responsible for releasing?
Radiopharmaca, radioactively labeling of pharmaceuticals for images of oncological treatment. Requires Dutch Gov. approved degree to do.
Urgent release needed, QP does not want to release?
“As coach of QPs I would ask them what is their concern and keep asking questions utill insight in own descision and the issue - than I might think with them to risk based take away the doubt, directly or after some thinking time. As PS my role was to convince QP’s to release based on logic objective thinking and GMP knowledge. Key is to have no patient risk and to risk based mitigate compliance issue. I’m good at that, ask Ron/Johan/Michiel/Jeroen.
S: failed camera detection on BL filling i.c.w. crashes, alu-alu BL atozet.
T: convince Eyke a experienced QP
A: came to a sampling plan to open all pockets of hundreds of blisters. Very labour intens. I pitched plan, X-ray device from Oss.
R: samples with X-ray device (destructive test), batch released.”
What if the amount of orders to release exceeds available QPs?
“Important to make clear choices/prios.
S: Recently QROlv2 team involved QN CS630 open freezer door
T: As this gave enormous workload I had to set priorities
A: I put one QRO in charge of the deviation and gave him full-time commitment, other 2 collegues did all regular tasks by cancelling all meeting except Dev.Man.
R: Clear roles and responsib. Deviation was handled adequately as quickly as is possible. “
