Job Description

Join Eisai - Empowering Lives, Transforming Healthcare At Eisai, we are on a mission to satisfy unmet medical needs and elevate healthcare for patients, their families, and caregivers. Our commitment to human health care (hhc) is the driving force behind our breakthroughs in neurology and oncology, with an unwavering focus on research and development. Why Eisai I nnovation Leaders : As a renowned Japanese pharmaceutical company, we have a rich history of developing innovative medicines. Notably, we are the pioneers behind the world\'s most widely-used treatment for Alzheimer\'s disease. Impactful Contributions : Join a team that is making a significant impact in the healthcare landscape. Your work at Eisai goes beyond a job; it\'s a contribution to improving lives globally. Fast-Paced Environment : Thrive in a dynamic and fast-paced environment where your skills and dedication can truly make a difference. We are not just expanding; we are evolving, and we want individuals who are ready for the challenge. Your Opportunity: If you are a highly-motivated individual seeking to be part of a company that values innovation, research, and making a real impact, Eisai is the place for you. Be a part of our journey as we continue to break new ground in healthcare. Your Responsibilities: Revision of Standard Operating Procedures (SOP), batch records (BMR/ BPR) as per CAPA / Periodic revision. Coordinate and ensure completion of internal / external trainings in stipulated time. Ensure availability of batch documents (From QA) in timely manner as per production requirement. Preparation of Change Control, Risk Assessments (For products / for major changes). Responsible for collection of data and preparation of investigation report for unplanned deviation, OOS/OOT, Quality Information, market complaints. Responsible for arrangement of areas for internal audit preparation of Drug Product Facility. Knowledge of TrackWise, Minitab, Ample Logic software is preferable. Qualifications: Proven experience in Drug Product Manufacturing - Production Documentation [OSD] in particular. The candidate should have a B Pharmacy / M Pharmacy with 3 to 6 years of relevant experience.

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