仕事内容Overall Job Purpose:
This position is responsible for supporting the site, department(s) and/or Project(s) to which they are assigned with respect to computer system development, validation, and maintenance. This role is responsible for procedural interpretation and training. The QA ensures inspection readiness within those areas supported and participates in regulatory agency inspections, as needed.
Job Responsibilities:
Provide direct quality oversight of computerized systems.
Review and approve documents supporting computerized systems and validation including, but not limited to, procedures, deviations, periodic reviews and change proposals.
Provide quality guidance and recommendations with regard to computer system issues.
Conduct gap assessments of global requirements and ensure implementation of the governing standards.
Review and approval of computer system (automation) related work orders.
Provide coaching, feedback and mentoring to QA and site personnel as it relates to computerized systems and validation.
Understand data integrity requirements and practice during validation and routine operation.
Participate in site data integrity strategy and assessment activities.
Lead/Support investigation and evaluation of computer system related incidents and/or deviations
Participate in the review/revision of global quality standards related to computerized systems, if needed.
Ensure areas are inspection ready and compliant to established systems/procedures.
Participate in and/or support regulatory inspections and audits.
Assist others in the interpretation of regulatory and corporate requirements supporting computerized systems.
Establish and maintain site quality system for computer system to meet regulations including Japanese GMP, Computer system guideline, GQSs and LQSs.
Attend Process Team(s) (e.g., Manufacturing, Utilities, QC, etc.) Flow Team(s) (i.e., FUME, QC, Engineering) Lead Team(s) (i.e., Data Management, Continuous Improvement, IDS, QA, etc.), as required.
(Business title: Manager/Sr. Manager-SQA )
経験・資格Required Experience: (mandatory for hiring)
Bachelor’s Degree (or above) in chemistry, engineering, computer science, mathematics or science-related field, or equivalent experience.
GMP work experience in a pharmaceutical industry
Experience with manufacturing process and/or computer system including validation.
Desirable Experience:
海外での就業経験もしくは日常的な英語での業務経験
Essential Skills / license: (mandatory for hiring)
ネイティブレベルの日本語力
TOIEC750点以上、又は英語を用いた業務経験がある方
Understand local and global applicable regulations (ex. CFR Part11 etc.).
Strong written and verbal communications skills.
Strong problem-solving and decision-making skills
Strong attention to detail.
Proficiency with GMP computer system validation including regulations governing them.
Strong leadership.
Excellent interpersonal skills and networking skills.
Ability to organize and prioritize multiple tasks.
勤務地
想定年収
福利厚生・待遇
勤務条件【勤務時間】8：45～17：30
【清算制フレックス勤務】適応あり。フレキシブルタイム：5時～22時内で勤務。(ただし、一斉休憩を除く)1日の必要最低労働時間：4時間(半日休暇時は2時間)一斉休憩：12時～13時
完全週休2日制（土・日曜日）、祝日、クリスマス、年末年始・夏期※年間休日125日 年次有給休暇、慶弔等
6か月間
試用期間中での賃金の違いはございません
昇給年1回、賞与年3回
保険（雇用・労災・健康・厚生年金保険）
Recruiting No.
社名
事業内容
【東証プライム上場 産業機器、ポンプ、航空、医療分野等の専門精密機器メーカー】 メディカル事業本部 カスタマーサービスグループ 品質保証担当
【総合電機メーカー直系の老舗コンサルティング会社】 業務改革・事業変革のコンサルタント
東証プライム上場 エネルギー会社グループ 風力発電事業会社
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