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JOB ID：63991
非公開求人
非公開求人
| 給与 | 800万円 〜 800万円 |
|---|---|
| 業種 | その他 |
| 勤務地 | 滋賀県 |
| 業務内容 | ・Reports To: Quality Director, CSS ・Department: Quality Unit - CSS ◎Quality Control leadership role in a fast-paced, customer focused organization.Performance driven culture rewards integrity to corporate values and delivery of results. Collaborative and inclusive work environment in a professional office setting. 【SUMMARY OF ESSENTIAL FUNCTIONS】 The following summary represents an ideal situation for a site with a high degree of operational excellence and a mature Quality Culture. Regardless, the Site Quality Manager will implement strategies and tactical objectives to move the site towards this general model over time. General allocation of time, effort, and attention: • 20% Site leadership: As a member of the Site Leadership Team working with the General Manager to create and sustain a site culture of Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development of site Quality Objectives, site Quality Plans,Quality Management Reviews, etc. • 60% Department leadership: - Overall responsibility for the site Quality Control and regulatory compliance functions including (but not limited to) those responsibilities listed below. - Oversee and execute all Performance Management Program (PMP) actions for the site Quality Control team. This includes professional development counselling, informal and formal performance appraisals and feedback, and talent development/succession planning. • 20% Personal Leadership: Professional development, managing work-life balance, strategic planning, etc. 【SPECIFIC SITE DUTIES, ACTIVITIES, AND RESPONSIBILITIES】 The following list is not comprehensive. Additional tasks and responsibilities may be assigned by Quality Director or arranged with the Site Leadership Team. Accountable and responsible for the following programs (as applicable to the site): • Internal Investigations on cGMP issues, trends, and customer complaints • Review and approve GMP documentation, including SOPs, Manufacturing Batch Records, validation protocols and reports, and executed Batch Records for cGMP compliance and clarity • Site Data Integrity programs • Process integration and procedural harmonization with other CSS sites • Raw materials and finished goods release processes • Communication and escalation of quality issues to Site Leadership Team and Quality senior management • Site Environmental Monitoring Program • Site Label Control, including review, release and approval process • In-process QC activities, including line clearance and room release, IN process and receiving inspections, and raw material/product sampling • Implement Global quality policies and standards and CSS network procedures at the site • Continuous process improvements, particularly as a function of site deviation rate and recurrent deviation rate • Maintain robust relationships, interactions, and communications with client counterparts • Site Recall/Quality alert program • Facility/equipment/process/analysis method/cleaning validation and qualification program • Site Risk Management • Site Change Control/ change management programs • Other duties as assigned by Quality Director |
| 応募資格 | 【Position Requirements】 • Knowledge and application ability for cGMP Regulation and Guidance for domestic and International Regulations for markets applicable to Catalent • Excellent interpersonal skills, including service mentality, active listening • Must be assertive without arrogance; confident without conceit • Ability to motivate, influence, and persuade colleagues up/down/and across the organization. • Articulate objectives, approach and business benefits for key stakeholders • Good attention to detail • Excellent PC skills • Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements • Comprehensive knowledge of regulatory organizations and requirements 【Education/Experience】 • Minimum BS Degree (or equivalent) in a Science, Engineering, or Pharmaceutical discipline. • Seven+ years of experience working in a chemical, pharmaceutical, food or relevant industry with at least five years’ experience in QA/RA areas with progressive responsibilities. • Experience in managing people, providing leadership, and implementing developmental plans for personnel. • Direct experience and working knowledge of Validation principles,including validation of processes, equipment, systems, analytical methods, cleaning, and transportation • Working knowledge of US and International cGMP regulations and experience working directly with the local and international regulatory agencies. • Experience with a variety of drug products and dosage forms. 【Knowledge/Skills】 • Must have a demonstrable record of implementing and maintaining quality systems; laying out a strategic plan and overseeing the tactical implementation, driving improved operational and quality metrics • Successful development and implementation of a quality strategy for a manufacturing operations environment. Successful in implementing consistent standards • Strong understanding of the functional areas of manufacturing, sourcing, materials management and quality control • Understanding of QA/QC GMPs and in interpreting and enforcing regulatory requirements • Fluency in English required. Multi-lingual skills are preferred • Must be resourceful, possess strong time management skills and be able to work with minimal or no supervision to achieve deadlines and objectives. |
| 福利厚生 / 待遇 | 退職金制度(勤続3年以上） 昼食補助あり（個人負担￥133/食） 通勤手当（条件により高速代補助） 引越が必要な場合、初期費用サポート |
| 勤務時間 | フレックスタイム制度：（コアタイム10：30～15：00） 標準勤務時間 9:00～17:45 残業：有（想定残業時間 10～25時間/月） |
| 休日休暇 | 年間休日123日 土、日、GW、夏季、年末年始）※祝日は、基本的に出勤です |