At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
- Locations: Telangana, Virtual
- Worker Type: Employee
- Worker Sub-Type: Regular
- Time Type: Full time
- Job ID: R0160222
Job Description
OBJECTIVES:
The Senior Specialist, External Quality Vaccines will support quality assurance activities for late-phase clinical programs and commercial vaccine launches. This role focuses on ensuring that manufacturing, testing, packaging, and shipment processes comply with Takeda’s Quality Management System (QMS), current Good Manufacturing Practices (cGMP), and global regulatory requirements. The position involves executing quality assurance systems and processes related to product technology transfer and lifecycle management to maintain product quality and compliance across multiple Contract Manufacturing Organizations (CMOs) and global markets.
ACCOUNTABILITIES:
Responsible for day-to-day interactions with contract facilities (CMOs, CTLs, and/or CSPs):
- Conducts/supports investigations on Good Manufacturing Practice (GMP) related issues or observations associated with audits, batch records and complaints.
- Reviews and approves (where applicable) manufacturing and testing deviations and investigations into out-of-specification results.
- Supports timely execution and completeness of change management at interface with CMOs (incl. supplier notification of changes) and of internal Takeda change management
- Reviews and approves batch production records and test records.
- Reviews and approves validation documentations
- Reviews and approves shipment or material transfer request
- Performs batch document review (Diluent, DS, DP, FDP) in support of batch disposition as per MAH requirements
- Ensures collaboration with and provides guidance to external manufacturing, project management, supply chain, Manufacturing Science and Technology and CMOs to ensure Q-Systems compliance and manages compliant and timely closure of deviations, CAPA, change controls and interim batch assessment as applicable.
- Executes regular Person in Plant QA oversight and leverages insights to ensure compliance and drive performance and continuous improvement.
- Manages document life cycle (incl. reviews, approval, make-effective and retirement) of GMP related documents, such as master batch records, risk assessments, etc. according to Takeda QMS requirement.
- In early stages of project, support, review and approve development, technology reports where applicable. Review of submission document ensuring data integrity to source data.
- Supports regulatory or Takeda global audits (including product specific inspections at CMOs), VBU Self-Assessment activities and risk mitigation activities identified in Risk Register.
- Maintains culture of teamwork, cooperation and continuous improvement.
- Other duties as assigned.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Minimum of Bachelor’s Degree in Pharmacy, Chemistry, Microbiology, or Life Sciences, or equivalent scientific discipline.
- Minimum of 5 years of experience in quality or regulatory compliance within the pharmaceuticals, biologics, or other related industry(ies)
- Experience of cGMPs, ICH and other relevant regulations. A broad based knowledge of domestic, and general knowledge of international regulations associated with manufacturing, testing and packaging.
- Excellent communication skills both oral and written.
- Experience with supporting product inspections from global Regulatory Authorities.
- Effectively represent Quality Assurance, both internally and externally.
- Experience in routine office software packages and specialized software applications as appropriate.
- Exhibit and promote Takeda Core Competencies.
LICENSES/CERTIFICATIONS:
- NA
PHYSICAL DEMANDS:
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
TRAVEL REQUIREMENTS:
- Some international travel may be required. Approximately 5 – 20%
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