QAシニアマネージャー

グローバル企業にて品質保証マネージャーとして担っていただきます。

仕事内容

Role objective
・Support Quality activities at Contract Manufacturing Organizations (CMO) and API suppliers by providing on time and effective quality oversight.
・Accomplishes quality objectives by planning and evaluating project activities. Support may include operations and validation. Essential Duties and responsibilities include, but are not limited to, the following: qualification, day-to-day operational activities, Quality Metrics, audit management, exiting/transferring activities, managing of a team.

Key Responsibilities：
1) Provide strong support team management for GQP Head on day-to-day basis
2) Plan, organize and lead periodic internal reviews with all stakeholders (e.g. GM, Audit, Supply Chain, launch management, Regulatory affairs and Cooperate Quality compliance)
3) Qualify, manage, support and supervise assigned CMO and API suppliers aligned with local regulation and the Sun Pharma Quality Management Systems and provide reports as required
4) Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine review
5) Manage (initiate and investigate) all significant quality issues associated with Drug Products or APIs originating from assigned CMO or suppliers (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion
6) Provide support to develop/implement/maintain/improve QMS in line with local regulation and Sun Pharma QMS
7) Perform other duties as assigned such as described below, but are not limited to:
a. Provide support for regulatory agency inspection readiness and requests
b. Maintain an annual auditing program, participate in technical visits and/or audits,
manage action plans and follow up on agreed upon CAPAs
c. Support business development for new CMO projects including due diligence audits and CMO qualification

Key Interactions：
Internal Stakeholders：
・Plan, organize and lead periodic internal business reviews with all stakeholder (e.g. GM, Audit, Supply Chain, Launch Management, Regulatory Affairs , Corporate Quality Compliance)

External Stakeholders：
・Perform reviews and manage quality issues for drug products/ APIs originating from assigned CMO.
・Communication with Health Authorities as required

応募条件

【必須事項】

・5 years of related experience in a GMP/GQP environment
・Expert skills related to investigations (e.g. Lean Six Sigma), Quality Agreements, and CMO management
Ability to identify key priorities necessary for and be able to author/implement global policies and procedures
・Expert skills related to OOS/deviation investigations, Quality Agreements, and CMO management
・Ability to identify key priorities necessary for and be able to author/implement global policies and procedures
・Strong understanding of technical pharmaceutical processes as well as risk assessment and risk management fundamentals/tools Strong GMP/GQP experience and knowledge, QA/QC and regulatory compliance (Japan, US,EU and other regulatory requirements)
・Experience in drug product sterile pharmaceutical/biologics manufacturing and QC is an asset.
・Strong interpersonal skills, excellent written and verbal communication skills, good presentation, negotiation and influencing skills
・Team player, task oriented, manage multiple complex priorities and keen on working in a cross-cultural working environment Certified Quality Auditor (e.g. ASQ) certification preferred
・English language fluency, both written and verbal, with the ability to communicate at all levels within the organization (e.g. TOEIC score of above 730); any other language fluency a plus

【歓迎経験】

・Minimum of 7 years of experience in QA/QC of Pharmaceuticals and/or Medical Devices
・Operational knowledge of pharmaceutical processing and packaging operations

【免許・資格】

【勤務開始日】

応相談

学歴

大学卒以上

雇用形態

正社員

試用期間

6ヶ月

勤務地

在宅可、東京

転勤の有無

転勤なし

受動喫煙防止措置

屋内禁煙

勤務時間

フレックスタイム制
コアタイムあり
　11:00 ～ 12:00
マネージャークラスはみなし労働制

勤務開始日

応相談

休日休暇

年間休日数：125
土日祝
年間有給休暇：入社月により変わります。初年度17～7日　 ～ 23日
法定休暇：年次有給休暇、産前産後休暇、介護休暇
特別休暇：年末年始休暇

年収・給与

年収　　1300万円～1500万円　経験により応相談

諸手当

通勤手当

昇給

年1回

賞与

年1回（夏）

採用人数

1名　

待遇・福利厚生

通勤手当：有

各種制度

健康保険：有
雇用保険：有
労災保険：有
厚生年金：有
定年：60歳

選考プロセス

１）書類選考
２）一次面接
３）二次面接
４）最終面接