QA Specialist - バイオ製薬企業

勤務地 東京都
雇用形態 正社員
給与 ¥8000000.00 - ¥10000000.00 per annum
専門 ライフサイエンス(医療機器・製薬・化学・ヘルスケア・農業・畜産),
職種 品質管理 / 品質保証,
お問合せ Hidetoshi Sato
JOB ID JO-2109-463641

※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.

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[Position] QA Specialist
[Location] 東京都/在宅勤務・フレックス制度あり
[Salary] 8〜10 million JPY ※Experiences and skills will be considered
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[Company Description]
外資系バイオ製薬企業

  • 感染症治療の製品を中心に事業を展開しています

[Responsibilities]
◆Specific responsibilities

  • Performs a wide variety of activities to ensure compliance with Good Quality Practices (GQP) and Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
  • Participates in developing Standard Operating Procedures (SOPs) to ensure quality objectives are met.
  • Maintains routine programs and processes to ensure high quality products and compliance with current GQP/GMP/GDP
  • Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
  • Normally receives very little instruction on routine work, general instructions on new assignments.

◆Essential Functions
Management

  • May act as a mentor to QA contactor with some task management responsibility.

◆Project involvement

  • May participates in cross-functional teams

◆Key Differentiating Contributions

  • Conducts final reviews prior to batch release approval by manager.
  • Works on routine QA operations such as Release, Change Control, Deviation, Product Complaint,
  • Quality Documents creation and revision, training.
  • Works on non-routine projects/assignments where analysis of situation or data requires a review of identifiable factors.
  • Exercises judgment within well-defined and established procedures and practices to determine appropriate action - identifies problems and generates alternatives and recommendations within defined processes.
  • Leads and coordinates reviews and investigations in situations involving deviations from governing procedures and processes.
  • Coordinates planning, organization, and implementation of projects within specified objectives.

◆Career Opportunities

  • GQP-tasks Responsible Managers role

[Requirements]
◆Knowledge, Experience & Skills

  • Demonstrates working knowledge of quality assurance systems, methods and procedures.
  • Demonstrates thorough knowledge of GQP/GMP/GDP, and the interface with other functions like manufacturing, distribution and maintenance.
  • Demonstrates audit and investigation skills, and report writing skills.
  • Demonstrates strong verbal, technical writing and interpersonal skills.
  • Demonstrates proficiency in Microsoft Office applications.
  • Excellent Japanese and English general communication skills
  • Knowledge of six sigma, LEAN and root cause analysis tools used for identifying and correcting deviations is preferred.

◆Typical Education & Experience

  • 4+ years of QA relevant experience in pharmaceutical or chemical related field and a BS or 2+ years of relevant experience and a MS.
  • Prior experience in pharmaceutical industry is preferred.
  • Moderate knowledge and experience in analytical, process chemistry and/or formulation development

[Welfare]

  • 健康診断、予防接種、健康推進活動
  • 育児休業、看護休暇、短時間勤務
  • 介護休業、介護休暇、短時間勤務
  • 職場での問題、家族・本人の病気、ライフプランニングに関してカウンセリング、サポートするサービス
  • 退職金制度、確定拠出年金制度
  • 万一の病気や事故で働けない場合の補償
  • 業務に必要な知識の学習、スキルアップを支援

[Holidays]

  • 有給休暇:年次により付与(最高年間20日/2年間有効、最高40日)
  • 特別休暇:慶弔休暇、産前産後休暇等
  • ボランティア休暇


Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Reference: JO-2109-463641
#LI-REMOTE
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance