Full-Time

Batch Disposition Senior Specialist

Confirmed live in the last 24 hours

Takeda

Takeda

10,001+ employees

Global biopharmaceutical company focused on R&D

No salary listed

Mid, Senior

Pisa, Province of Pisa, Italy

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Required Skills
SQL
Requirements
  • Degree in scientific disciplines
  • A minimum of 3/5 years of experience in Quality or Manufacturing departments within pharmaceutical companies required.
  • Good knowledge of JDE systems (ERP system), MODA, SQL*LIMS Labware, Trackwise.
  • Good knowledge of personal computer programs (Microsoft Office: Word, PowerPoint).
  • Good knowledge of written and spoken English.
  • Good understanding of GMP and pharmaceutical regulations
  • Good communication skills
  • Good ability to work in a team
  • Precision and accuracy in executing assigned work
  • Knowledge of Annex 1 of cGMP for sterile products
  • Knowledge of ISO 14644-1; 14644-2 regulations
  • Knowledge of the production process for sterile products
Responsibilities
  • Organize batch disposition activities, based on site prioritization and the Supply Chain requests.
  • Complete the batch record review within the specified timeline autonomously, ensuring accuracy and compliance.
  • Collaborate autonomously with department personnel to carry out R&I activities (materials and product bulk lots).
  • Assure the execution of the release activities of medicinal lots following guidelines and local/global procedures in compliance with quality standards.
  • Provide Quality technical support to the Manufacturing and Engineering Department, solving issues and making decisions.
  • Support the deviation issuing related to the manufacturing process
  • Execute the batch record review within the defined timelines, ensuring also the approval of the AQL test and VI overall results
  • Guarantee the release of the medicinal lots within the requested timelines ensuring the respect of the Lead Time Fulfillment KPI and the compliance with the relevant specification as per Licence
  • Guarantee the shipment of the medicinal lots within the requested timelines according to the Quality Agreements with the Plants Rieti and Vienna
  • Support the Receiving and Inspection process in accordance with global/local procedure requirements and cGMP for materials and product bulk lots
  • Guarantee the quality support to the Manufacturing department, ensuring that potential issues with GMP impact are handled by the deviation management system
  • Support investigation and CAPA management as needed
  • Coordinate the activities for a proper training program within the Batch Disposition department
  • Guarantee the processing of the Key Performance Indicators (KPIs) related to the pertinent area
  • Take part to meetings/alignment/divisional projects
  • Execute assigned activities accurately following instructions closely to ensure detail-oriented outcomes.
Desired Qualifications
  • Belonging to protected categories (Law No. 68/99) will be considered a preferential qualification.

Takeda Pharmaceutical Company Limited is a global biopharmaceutical firm that focuses on developing and delivering treatments and vaccines. The company invests heavily in research and development to create new molecular entities (NMEs) and has a pipeline of 11 NMEs, aiming for up to 15 product launches by FY2024. Takeda's products are designed to meet the needs of healthcare providers, hospitals, and patients around the world. What sets Takeda apart from its competitors is its strong commitment to patient-centric values and environmental sustainability, recognizing the connection between human health and environmental health. The company's goal is to innovate and provide life-changing therapies while ensuring that patient needs are prioritized.

Company Size

10,001+

Company Stage

IPO

Headquarters

Tokyo, Japan

Founded

1781

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Simplify's Take

What believers are saying

  • Takeda's collaboration with BridGene is worth up to $770 million.
  • The company is expanding its market presence in emerging Asian economies.
  • Takeda's focus on personalized medicine aligns with industry trends.

What critics are saying

  • Antitrust litigation over Amitiza could harm Takeda's reputation and finances.
  • A data breach incident poses significant cybersecurity and legal risks.
  • The telehealth market's rapid changes may affect Takeda's investment in American Well.

What makes Takeda unique

  • Takeda has a 240-year history in the biopharmaceutical industry.
  • The company emphasizes patient-centric values in its operations.
  • Takeda has a robust pipeline with 11 NMEs and aims for 15 launches by FY2024.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Wellness Program

Tuition Reimbursement

Company News

ETF Daily News
May 11th, 2025
Tudor Investment Corp ET AL Decreases Stock Holdings in American Well Co. (NYSE:AMWL)

Takeda Pharmaceutical Co. Ltd. acquired a new stake in American Well in the fourth quarter worth about $564,000.

CyberNews
Apr 15th, 2025
Hackers want $75,000 for data allegedly stolen from Takeda

A new account on an illicit forum bearing the moniker "beltway" claims that in April 2025, it exported around two million rows of user information from Takeda.com.

MLex
Mar 4th, 2025
Meijer seeks quick appeal in US antitrust case against Takeda

( March 4, 2025, 17:06 GMT | Official Statement) - MLex Summary: Meijer asked a US federal judge for leave to immediately appeal an order that sent its antitrust case against Takeda Pharmaceuticals over the drug Amitiza to arbitration.

BioSpace
Mar 3rd, 2025
Takeda-Protagonist Drug for Incurable Cancer Reduces Need for Blood Withdrawals in Phase III Trial

Protagonist, which will receive a $25 million milestone from Takeda thanks to the positive results, plans to submit the findings to regulators.

Access Health
Mar 3rd, 2025
Strengthening Access to Medicines in Southeast Asia: Highlights from Southeast Asia Access to Medicine (SEA AtM) Summit

ACCESS Health International, in collaboration with AVPN, SingHealth Duke-NUS Global Health Institute, and Takeda, successfully co-hosted the first Southeast Asia Access to Medicine (SEA AtM) Summit in Bangkok.