Quality Assurance Expert

at  Takeda Pharmaceutical

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JOB DESCRIPTION

Job title: Quality Assurance Expert
Location: CHE - Neuchâtel

EDUCATION AND EXPERIENCE REQUIREMENTS

Critical / Key skills (Compétences critiques / clés) :

• Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy, or Quality Management applied to industrial process or equivalent industrial experience
• 2-5 years of experience within a GMP environment, pharmaceutical and/or biotechnological industry
• Ideally demonstrated experience in Quality Assurance

KEY SKILLS, ABILITIES, AND COMPETENCIES

Technical skills:

• Knowledge of GMP, FDA, EMA, ICH, Pharmacopeia regulations, quality system standards and data integrity principles
• Knowledge in auditing and inspection against regulatory / quality standards
• Knowledge and interest in detailed manufacturing operations (e.g. engineering designs, automation documentation, biotechnological processes)

Language & IT skills:

• Fluent in French and minimum intermediate level in English
• Mastery of MS Office pack

Personal qualities:

• Positive and self-motivated
• Accountable
• Solution oriented, pragmatic, ability to simplify complexity
• Good analytical skills
• Good organizational skills, structured, rigorous, able to manage priorities in a fast and dynamic environment with a strong emphasis on maintaining high quality standards
• Proactive, autonomous continuous improvement mindset
• Team player, prepared to work in team-based culture including manufacturing personnel on the

PRIMARY DUTIES

This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department. Within this position, QA Expert is responsible for compliance and quality oversight related to activities throughout the manufacturing and release process of bulk drug substance (BDS).
The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities as well as for all improvement projects for the site. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
Participation in GMP zone audits as well as internal and external regulatory inspection is an integral part of his/her activities. The QA expert is accountable for the promotion of continuous improvement and involved related initiatives.
The QA Expert has to understand and apply Takeda EHS guidelines and commitments policy, take care of itsown safety, report risk situations and improvement opportunities to supervisory personnel.
The job holder can act as back up of other QA Experts and QA Manager/Supervisor as requested.

RESPONSIBILITIES

Batch Record Review:

• Review batch records (paper-based and/or electronic format in MES system) according to procedures and guidelines/regulations.
• Ensure their timely transmission to the respective department.
• Verify in-process critical manufacturing steps and calculations during working hours.
• Prepare the batches for the QP batch certification.

Documentation:

• Prepare, evaluate and approve new or revised controlled documents (procedures, SOPs,

forms, SISA, specifications, etc.) .

• Ensure timely review and implementation of documentation for accuracy and compliance
• Propose continuous improvement of documents in direct partnership with relevant SME.

Deviations:

• Lead or review and approve deviations in the framework of production and laboratory events within quality systems to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant corrective/preventive actions

SPECIFIC RESPONSIBILITIES RELATED TO EXPERT OR SPECIALIST POSITION:

The QA Specialist and the QA Expert can be responsible for the same activities aforementioned.
However, the QA Specialist is mainly accountable for local and low-criticity tasks whereas the QA Expert can be involved in inter-facility, global activities and major/critical issues. The proportion of time allocated to the aforementioned tasks differ.