Commercial Quality, Senior Analyst

Job Description

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Job DescriptionAbout the role:

The Commercial Quality, Senior Analyst is responsible for ensuring the quality of processes and product outputs. This role involves defining and specifying activities, processes, and standards to meet quality requirements, as well as auditing, monitoring, and determining the quality of processes or outputs. The role supports Takeda's mission by ensuring compliance with internal and regulatory standards, thereby maintaining product integrity and safety.

Accountabilities:

Define and specify activities, processes, and standards to fulfill quality requirements

Audit, monitor, and determine the quality of processes or outputs

Conduct product integrity testing, including coloring, fitting, pattern, and wet processing

Report on process deviations and defects

Manage projects and processes independently with limited supervision

Coach and review the work of lower-level professionals

Address moderate scope problems and apply judgment within defined procedures and policies

Applies basic quality assurance principles in routine situations, requiring guidance to ensure compliance and safety

Understands and applies basic safety assurance concepts under close supervision to maintain workplace and product safety

Conducts audits with ongoing supervision, applying basic auditing principles in straightforward situations

Identifies flaws and learns to apply corrective and preventive actions with guidance

Applies investigation techniques in simple cases with supervision, ensuring thorough examination and compliance

Follows established change control procedures with supervision, understanding their importance in quality management

Utilizes Quality Management Systems with guidance, ensuring adherence to regulatory standards

Applies basic quality control principles with some coaching, ensuring product integrity

Focuses on details, identifying key elements in tasks with supervision to maintain high quality standards

Develops writing skills, understanding basic grammar and punctuation to produce clear documentation

Gains practical experience in biotechnology, performing tasks with guidance to understand biological processes

Enhances interpersonal communication skills, requiring ongoing supervision to effectively communicate within the team

Skills and qualifications:

Verifiable graduate degree in Pharmaceutical Chemistry (mandatory)

3- 5 Years of experience in Quality Assurance processes

Substantial experience in recall, product release and inspection, SOP documentation, supply chain compliance

Supplier relationship, license management

User knowledge with SAP, TrackWise and Veeva is a plus

Desirable regulatory affairs experience

Proactivity, strategic planning, resource optimization

Active collaboration with multidisciplinary teams

Learning agility

As a solid professional, you receive assignments with objectives and goals, providing guidance to employees based on established policies. Your work is reviewed by management to assess goal achievement and adherence to policies, with opportunities to recommend policy changes within your unit or sub-unit. You address moderate scope problems, applying judgment within defined procedures and policies, and act as an advisor when needed. Your role involves frequent use of industry practices and general knowledge, ensuring project completion on schedule, primarily liaising internally with subordinates and supervisors, with minimal external contacts and guidance.

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