Tata Consultancy Services - Experience certainty

Digital Transformation / デジタルトランスフォーメーション
[DTS] Validation Leader (System)
職務内容 . Project Management, Knowledge on GxP and Computer System Validation (CSV) , Customer SOP, aware of SDLC and deliverables, – Associated experience in pharmaceutical R&D domain would have an added advantage
. Excellent communication skill and exposure on handling customers at onsite. Ability to work as a team player in a consulting environment.
. Candidate must be aware of SDLC and deliverables- should be able to provide overall SDLC guidance and support
. Ensure that the project deliveries are in line with Customer SOP and quality framework
. Reviews requirements and functional solution and defines the SDLC/validation strategy
. Leads the relevant SDLC activities as defined in the validation plan. Ensures SDLC deliverables are accurate and appropriately approved
. Actively audit projects and systems to ensure that the appropriate validation activities are carried out in compliance with regulatory requirements and corporate standards
. Ensures the validation and testing activities are appropriately delivered
. Should have knowledge of Risk Management framework, mitigation and contingency plans, risk treatment options
 
登録資格 【必須】
Must have worked in the CSV role for more than 5 years
Must have knowledge of the SDLC processes
Must have worked in Pharma Industry for more than 5 years
Must have knowledge of Testing Processes
Either have education or working knowledge of Pharma domain

【歓迎】
Worked with European and US customers 
待遇  ■雇用形態
正社員
管理監督者分類:無(ケースによっては有)
労働時間区分:みなし労働時間制
みなし労働時間制の種類:専門業務型裁量労働制
一日当たりのみなし労働時間:8時間

■給与
月給:経験により 
※経験・能力など考慮の上、当社規程により決定
裁量労働手当:60,000円〜80,000円
残業手当:なし
昇給:あり
賞与:あり

■勤務時間
9:00〜18:00
(実働8時間・フレックスタイム制有、コアタイム10:00〜16:00)

■休日/休暇
年次有給休暇(初年度10日 ※入社日によって異なる場合有)、完全週休2日制(土曜日・日曜日)、祝日、年末年始、慶弔休暇、育児・介護休業

■福利厚生
保険:健康・厚生年金・雇用・労災保険
制度:財形貯蓄・確定拠出年金・カフェテリアプラン(選択型法人会員福利厚生サービス)
   ※財形貯蓄・確定拠出年金は正社員のみ対象
施設:法人会員施設(スポーツクラブ、温泉保養所、ホテル他)
 
勤務地  東京 


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