quality - group manager of quality assurance: 大手外資系製薬メーカー(1200~1400万円) in 東京都

job type
¥ 12,000,000 年棒
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job details

job category
job type
¥ 12,000,000 年棒
・Higher university degree (e.g. MS or Ph.D.) in Biochemistry, Chemistry, or another related science
reference number
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job description




・Ensure that all aspects of the manufacturing products for *** at identified CMOs and Suppliers comply with the requirements of the *** Quality Manual and Policies and meet all relevant cGMP, regulatory and legislative requirements.

・Provide leadership, direction and support to third parties (both local and global sup-pliers) and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties in a safe manner. This includes regular site visits to local suppliers.

・Lead External Supplier’s Qualification process in conjunction with the QAM.

・Ensure that QAMs are meeting requirements associated with NOSCEE , Quality Agreements, audit plans, supplier qualifications, Batch Record Qualification and change control.

・Maintain  current  knowledge of local and international regulatory  and legislative  re-quirements and trends  to ensure  that technical  support  on all quality  related  mat-ters  is provided  to the third  parties.

・Responsible for driving/initiating External Supplier Quality Risk assessments in con-junction with the QAM for all External Suppliers within the responsibility of the team. Gaps identified in Quality Systems will need to be remediated. Execution is to be monitored to ensure that issues are suitably addressed.

・Lead site readiness for regulatory inspections at External suppliers where appropriate.

・Lead site remediation from regulatory inspections and audits.

・Review all Critical Quality Issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc) in conjunction with the QAM according to the Quality Assurance Agreement and the *** Quality Manual. Ensure investigations are correctly executed. Ensure they are updated in AQWA (Adaptable Quality Workflow Application)

・Responsible for assessing Quality trends and leading Continuous improvement for processes and product quality performance across external suppliers.

・Escalate all potential quality issues as per the *** escalation policy and to higher level management, especially the ESO QA Head, and initiate all actions as defined. This includes escalation of issues due to inadequate resources to perform quality oversight and duties.

・Act as deputy for the ESO QA head. This includes escalation of quality issues to ESO Global QA head in absence of the ESO QA Head.

・Higher university degree (e.g. MS or Ph.D.) in Biochemistry, Chemistry, or another related science

・Fluent in speaking / writing in English. Local language
fluency preferred

・10-15 years working experiences in a GMP environment like QA operations, pharma production, R&D, QC and/or other related area mandatory.

・Fluent in speaking / writing in English. Local language fluency preferred

年収1200 ~ 1400万円