At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
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 deviationsParticipate 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 )
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 industryExperience with manufacturing process and/or computer system including validation.弊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。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半年以上ある方Understand local and global applicable regulations (ex. CFR Part11 etc.).Strong written and verbal communications skills.Strong problem-solving and decision-making skillsStrong 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.【就業場所】 西神工場（神戸市内）
従事すべき業務の変更の範囲 ：当社業務全般
就業場所の変更の範囲 ：将来のキャリアの一環として、神戸本社・東京支社・西神工場・ 海外オフィスでの勤務をする場合もありうる
【給与】当社規定により優遇します
【諸手当】住宅手当、通勤交通費など
【昇給】有り
【賞与】年一回 個人業績結果及び会社業績結果に基づく業績変動賞与を翌年3月に支給する。
【勤務時間】8：45～17：30
【時間外手当】なし
【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
【在宅勤務制度】有
【受動喫煙対策】あり 就業場所 全面禁煙
【休日休暇】完全週休2日制（土・日曜日）、祝日、年末年始・夏期
*年間休日125日、年次有給休暇、慶弔等
【保険】雇用・労災・健康・厚生年金保険
【定年制】有（60歳）
【継続雇用制度】：有（65歳まで）
【有給休暇】
入社月 １－６月 ７月 ８月 ９月 １０月 １１月 １２月
10 5 4 3 2 1 0
【試用期間】 6か月間 試用期間中での賃金の違いはございません
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