QA Expert - Senior  

​
Experis® is a global leader in IT professional resourcing, permanent recruitment, project solutions, and managed services. With over 25 years of experience in Switzerland and offices in Zürich, Basel, and Geneva, we connect top IT talent with leading companies. Our mission is to help professionals unlock their potential and thrive in dynamic, future-ready careers.
 

​

• 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 or 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 its own safety, report risk situations and improvement opportunities to supervisory personnel.

Release activities
- Inspection and Release of raw material and external BDS
- Ensure Release planning is up to date
- Participate to the feeding of the KPI of release of raw materials
- Ensure activities associated with the archiving as required
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.).
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.
Quality 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 departments (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 appropriate 
- Ensure respect and commitment to EHS guidelines

​
If you are interested in this opportunity, we look forward to receiving your CV or if you have any questions, contact Elaine Kanwar on +41 61 282 2223

Check out all open positions at Experis at www.experis.ch

Due to Swiss work permit restrictions, we can only consider applications from EU citizens or holders of valid working permit in Switzerland.