339015BR
Mar 17, 2022
Japan

Job Description

Quality Management System:
Implement and maintain the local Quality System in the areas within scope, in accordance with the Novartis
Quality Manual, the CO Quality Plan, and the local regulatory requirements through:
• Implementation of global quality documents in the Japan CO
• Contribution to the CO Quality Plan preparation, implementation and follow-up
• Contribution to the Quality Risk Assessments
• Management of local quality documents
Ensure adequate reporting of adverse events / technical complaint / compliance issue in accordance with
company procedures
2. Metrics:
Report monthly Key Quality Indicators (KQIs) within scope of responsibilities.
3. Vendors:
Contribute to ESP (External Service Providers) assessment for local outsourced clinical
development/pharmacovigilance/post-marketing surveillance activities and provide guidance and oversee
ESP and POP (Patient Oriented Programs) activities in the CO through interactions with the line-functions
and stakeholders involved according to current SOPs.
4. Marketing:
Assist the Marketing Program Owners (MPOs) in developing the CAPA Plan to correct any deficiencies
identified during the POP vendor assessment and sign the CAPA plan.
5. Audits:
Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance related audits,
at vendors and at investigator sites.
6. Inspections:
Ensure the preparation, facilitate the conduct and coordinate the follow-up of GCP and Pharmacovigilance
related local and foreign Health Authority inspections at the CO, at vendors and at investigator sites.
7. Quality Issues Management:
Ensure that deviations and issues are properly managed in AQWA including the respect of the escalation
process.
8. Training:
Contribute to trainings in the areas within scope
• Reviewing training materials
• Providing/supporting Quality trainings
100% timely delivery of all training requirements including compliance

Diversity & Inclusion / EEO

ノバルティスは、優れた包括的な職場環境と、私たちがサービスを提供する患者さんや地域社会を代表する多様なチームの構築に取り組んでいます。

Minimum Requirements

Education: • Degree in Life Sciences or related fields
Experience/Profess
ional requirement:
• Min. 3 years’ experience in the pharmaceutical industry in a
relevant field such as quality assurance, regulatory affairs,
pharmacovigilance, clinical development or a directly related area
English Skill: • Minimum in speaking and writing

Global Drug Development
QA GDD
Japan
全国
フルタイム
正社員
いいえ
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339015BR

Senior Dev QA Specialist

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