Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Quality Disposition in our Lexington, MA office.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Here, you will be a vital contributor to our inspiring, bold mission.
This position has responsibility for performing Batch Disposition activities for Global API in accordance with their Registered Approvals or Marketing Authorizations, their Manufacturing Authorizations, Takeda Global Quality Standards and Procedures, and the princilples and guidelines of current Good Manufacturing Practices.
- Assists with the prioritization and coordination of batch release activities, to prevent supply disruption.
- Review of batch record information from Contract Manufacturers/ Suppliers, and compilation of batch documentation for review according to Takeda requirements and SAP inspection plans.
- Transfer needed information from Contract Manufacturers/ Suppliers batch documentation into Takeda systems e.g. LabLIMS and SAP/BPR
- Prepare and review batch documentation for release, including upload of batch certificates to the repository.
- Archive batch documentation according to Takeda and customer requirements.
- Perform Technical Release of products in SAP/BPR based on release certificates from Contract Manufacturers/ Suppliers
- Support other functions as needed with e.g. PQR preparation, deviations, change controls, and CAPA.
- Maintenance of product lists and Quality relevant SAP master data.
- Provides other support/input as needed to ensure the effective oversight of Contract Manufacturers/Suppliers and compliance of OncESSM procedure/processes with Takeda requirements, and GMP.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor's Degree in Pharmacy, Chemistry, Biology, or related discipline
- Minimum 6 years of QA/QC experience in the pharmaceutical industry
- Demonstrated teamwork, initiative, and problem-solving skills
- Fluent in English language oral/written communication skills
- Skills required:
- Communication ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
- Analytical Skills ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
- Teamwork ability to establish professional relationships and rapport with internal and external peers and higher-level management
- Proactiveness ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
- Regulatory Understanding broad based knowledge of domestic and general knowledge of international regulations associated with manufacturing and packaging
Core Competencies / Skills
- Critical Thinking
- Digital and analytical skills
- Investigation and problem solving
- Good communication skills engaging stakeholders: site, business, network, company, regulators
- Risk identification, evaluation and management
- Continuous improvement
- Enterprise thinking, finding innovative ways to improve compliance and process
- Elevates capabilities of the organization
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.