SHE
SHEは何の略ですか?
S - Safety
H - Health
E - Environment
HVAC を管理するのはUtilityですか、それともFacilitiesですか?
Answer: Utilities
ENGの人数は何人ですか？
Answer: 5 名
- Nishimura-san x 2, Takai-san, Mizumoto-san, Okunaga-san
新しく来る人は誰ですか？
Yamamoto Kentaro-san
ASで一番勤続年数が長い人は誰ですか？
Sumikawa Midori-san
True or False - SHE team leads the safety, health, environmental activities at Maihara site in accordance with domestic laws and regulations, and not AZ global standards
False - SHE team needs to manage Safety, Health, and Environment activities in accordance to both domestic and AZ global standards
セキュリティの管理はUtility or Facilitiesですか？
Answer: Facilities
Takai-sanの first name はなんですか？
Answer: Ryoichiです。
True or False - Validationとは、医薬品や医療機器の新規製造の設計とプロセスが正しいかどうかを確認する一連のタスクです。
Answer: True
ASの人数は何人ですか？
Answer: 4人
- Sumikawa-san, Fujita-san, Kanbe-san, Tanigawa-san
What are the 3 Pillars in AZ Sustainability?
①Access to healthcare
②Ambition Zero Carbon
③Corporate ethics & transparency
④Enviromental conservation
Answer:
①Access to healthcare
③Corporate ethics & transparency
④Enviromental conservation
Facility team outsources its management operations to TMES vendor - Yes / No?
Answer: No
Which statement is False about ENG?
① Conduct installation, automation, and renovation of equipment for current issues and future plans of Maihara site
② Analyzes the life cycle of Maihara site equipment and propose optimal future concepts for pharmaceutical manufacturing.
③ Project Engineers are responsible for managing the budget and schedule of their assigned projects, except for large-scale projects
④ Handles the engineering part of various inspections related to the Maibara Plant (self-inspection, GQA, contractor, authorities, etc.).
Answer: ③
Pick 2 departments Validation does not directly support?
① AS
② NPI & Pack Dev
③ Production planning
④ Quality Control
Answer: ① & ③
What is the abbreviation of AS?
What is considered Health in AZ SHE?
A - Occupational (Physical health) + Occupational (Mental health / Well-being)
B - Occupational (Physical health) + Occupational (Mental health) + Occupational (Mental health / Well-being)
C - Occupational (Physical health) + Occupational (Mental health) + Occupational (Mental health / Well-being) + Ergonomics (human factors)
Answer: C
When a technical issue occurs in the utility systems at Maihara Factory, what is the most appropriate response?
A- Shut down all utility systems immediately.
B- Analyze the issue, find the root cause, implement countermeasures, and verify their effectiveness.
C- Call the vendor and outsource the problem entirely without internal review.
D- Only document the issue for future reference.
Answer: B
米原工場でユーティリティー設備に技術的なトラブルが発生した場合、適切かつ包括的な対応として最も正しいものはどれですか？
A. 問題の規模に関わらず、すべてのユーティリティーシステムを直ちに完全停止する。
B. 技術的な分析を実施し、原因を究明し、対策を立案・実行し、その有効性を検証する。
C. 内部評価を行わず、即座に問題解決を外部業者に全面的に委託する。
D. 問題を記録するだけで、即時の対応は行わない。
How many direct reports does Fusa-san have？
Nishimura-Rui, Okunaga-san, Mizumoto-san, Takai-san, Sumitomo-san, Kentaro-san
What does the SVMP (Site Validation Master Plan) do?
① It is a document only required for non-GMP manufacturing facilities.
② It is a document that details validation activities to ensure regulatory compliance in pharmaceutical and medical device manufacturing.
③ It is a document which serves solely as a schedule for employee leave and holidays.
④ It is a document that is used to validate activities in Quality laboratories, not in manufacturing.
Answer: ②
Which of the 2 statements are appropriate tasks for AS (Administrative Support)?
A - Choose suppliers only based on the lowest price, ignoring internal assessments.
B - Oversee the management of commuter vehicles at the Maihara site.
C - Rely on external consultants for contract negotiations, with no internal participation.
D - Handle payment approvals, with involvement in supplier registration or communication.
Answer: B & D
A. 価格のみで取引先を選定し、社内審査を考慮しない。
B. 米原工場で通勤車両を管理。
C. 全ての契約交渉を外部コンサルタントに委託し、自ら関与しない。
D. 支払い承認だけを担当し、取引先登録やコミュニケーションには関与しない。