Quality Assurance Expert
Date de publication :
21 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Neuchatel
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Job Description
Job title: Quality Assurance Expert
Location: CHE - Neuchâtel
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
(CAPA).
- Ensure deviation and CAPA management documentation in a timely manner.
- Develop and implement appropriate tools and methods to perform standard investigation
and problem solving techniques, to close exception documents, and to ensure
appropriate adherence to quality documents (procedure, run sheets, material
specification, etc.).
- Assist in performing complaint investigations, as needed.
Change Controls:
- Evaluate internal and/or external change requests and follow deployment through change
control according to procedures, GMP requirements and regulatory licenses.
- Act as change approver for routine and emergency chnges. This includes performing evaluation, assist, review and prepare corresponding documentation until timely closure of all tasks and change control records.
Compliance:
- Perform internal facility GMP audits of manufacturing and support areas
- Participate in external regulatory agency inspections, observation responses and regulatory submission preparation as required
Quaity in Operations:
- Provide quality oversight, i.e.support and guidance to production team units in their routine activities directly on the floor, fostering strict application of cGMP concepts and quality systems.
- Participate in day-to-day operational decisions as needed, including on-call service.
- Report any potential issue detected on the floor and proposes adequate guidance for documentation and correction.
- Establish efficient partnership with production and associate departements (e.g: maintenance, engineering, QC, etc-) to define and review detailed action plan for any process modification or improvement.
- Participate and/or lead meetings with production and other departments as approriate.
- Ensuire respect and commitment to EHS guidelines.
Various:
- Provide training to employees in relevant areas (e.g. GMP, GDP, Batch review, etc.).
- Participate and support activities such as quality documentation approval, RAM approval, training profiles management, archive activities, monthly KPI preparation, annual PQR preparation and other tasks as appropriate.
- Participate and/or lead improvement initiatives and site enhancement projects.
- Report out of findings/issues to functional leaders and higher management as needed.
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.
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
Locations
CHE - Neuchatel
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time