NEW 外資系製薬メーカー 品質保証/コンピュータシステム品質保証(担当課長・課長)

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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. 【通勤について】 同社では社員のウェルビーイングと生産性の観点から、自宅最寄り駅から勤務地までの通勤距離が90?以内かつ最安値の公共交通機関の所要時間が90分以内の範囲を、通勤可能上限としています。それよりも遠方にお住まいの場合は、通勤可能な範囲にご転居いただくことを原則としております(借上社宅の貸与あり)。車両通勤を認める場合においても、上記を適用します。
経験・資格	※求人情報の応募要件全てに該当しなくても、企業様に対して内々に打診したり相談することが可能な場合もございます。一つでも当てはまる方は前向きにご検討下さい。 【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. ※更なる詳細事項は、カウンセリング（面談）時にお伝えします。
想定年収	※ご経験、スキルにより応相談
勤務地	兵庫県神戸市
企業データ	会社名 外資系製薬メーカー 資本金 100億円以上 従業員数 1000名以上 事業内容 医薬品・畜産薬の製造、輸入、販売、研究開発
ひとことコメント	創業時から研究開発に注力。特化した分野で確かな地位を築く。学閥なし、プロパー優遇なし、職位による差別なし。人物をフェアに見る社風。
Recruiting No.	02000692001014