Make your mark for patients
We are looking for a Qualification QA Specialist – Automation area who is attentive to details and accuracy, team‑oriented, and analytical to join us in our eDI TS & Qualification team, based in our office in Bulle, Switzerland.
About the rôle
As an eDI TS & Qualification QA Specialist, you will oversee QA reviews for automation and manufacturing and lab equipment. You will act as the electronic data integrity expert, ensuring its implementation and compliance at the Bulle manufacturing site. You will also support QA oversight and contribute to improving the Quality Management System.
Who you’ll work with
You will report to the eDI TS & Qualification QA Manager and work within a team of five colleagues who foster a highly collaborative environment. You will also partner with cross‑functional teams, including QA, Qualification, and IT experts, to implement improvements and support new initiatives.
What you’ll do
1. Review and approve automation and qualification deliverables for MES, DCS, and lab equipment
2. Approve audit trails and access reviews according to GxP standards
3. Perform review of SIP documentation
4. Develop, implement, and maintain electronic data control processes and procedures
5. Provide QA oversight for manufacturing and QC lab equipment compliance
6. Support process simplification, continuous improvement, and new data integrity SOPs
7. Monitor and report key performance indicators for data integrity control
8. Define data flows and review critical data for QA integrity
9. Participate in internal and external audits as required
Interested? For this role we’re looking for the following education, experience and skills
10. 5+ years in pharma, with biopharma manufacturing and automation/CSV expertise
11. Strong knowledge of MES/DCS qualification and lab equipment software
12. Expérience with LIMS and Empower considered an advantage
13. Ability to coordinate complex projects and meet critical deadlines
14. Fluency in French and English with strong communication skills
15. Strong GMP understanding, problem‑solving, negotiation, and proactive improvement mindset
Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!