Sr QA IT/CSV Compliance Specialist — Thermo Fisher Scientific (Schweiz) AG
- Location
- Allschwil
- Contract
- full-time
- Posted
- 2 days ago
Role overview
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
- Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description
- As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.
- The successful candidate partners with cross-functional teams to drive quality excellence, oversee validation lifecycle activities, support inspections and audits, and maintain robust quality systems that enable Thermo Fisher Scientific's mission. Responsibilities:
- Serve as the Quality Assurance subject matter expert for IT systems, computerized systems, equipment qualification, and Computer System Validation (CSV).
- Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Degree in Chemistry, Biology, Microbiology, Engineering, Computer Science, or another relevant scientific or technical discipline.
Main responsibilities
- The successful candidate partners with cross-functional teams to drive quality excellence, oversee validation lifecycle activities, support inspections and audits, and maintain robust quality systems that enable Thermo Fisher Scientific's mission. Responsibilities:
- Serve as the Quality Assurance subject matter expert for IT systems, computerized systems, equipment qualification, and Computer System Validation (CSV).
- Review and approve validation lifecycle documentation including URS, risk assessments, FAT, SAT, IQ, OQ, PQ, validation plans, protocols, reports, and periodic reviews.
- Provide oversight of qualification and validation activities to ensure systems remain in a validated state throughout their lifecycle.
- Lead or support investigations, root cause analyses, CAPAs, change controls, and risk assessments related to computerized systems and equipment.
- Ensure compliance with Data Integrity principles, global GMP requirements, FDA/EMA regulations, 21 CFR Parts 210/211, applicable GAMP and ICH guidance.
- Review and approve SOPs, deviations, validation templates, and quality documentation supporting GxP systems.
- Track periodic reviews and audit trail reviews for computerized systems.
- Represent Quality during customer audits, regulatory inspections, and internal audits; support inspection readiness and responses.
- Collaborate with Engineering, Manufacturing, Validation, IT, and Operations to drive continuous improvement and compliance initiatives.
Key requirements
- Quality Assurance experience in a GMP-regulated pharmaceutical or biotechnology environment.
- Degree in Chemistry, Biology, Microbiology, Engineering, Computer Science, or another relevant scientific or technical discipline.
- Demonstrated experience in Computer System Validation (CSV), equipment qualification, and quality oversight of GxP computerized systems.
- Strong knowledge of FDA, EMA, global GMP regulations, 21 CFR Parts 210/211, Data Integrity, and ICH/GAMP guidance.
- Hands-on experience with investigations, CAPAs, change control, document management, and quality risk management methodologies.
- Experience supporting regulatory inspections, customer audits, and internal audit programs.
- Knowledge of computerized system periodic reviews, audit trail reviews, and computer system lifecycle management.
- Excellent technical writing, communication, analytical, project management, and problem-solving skills.
- Ability to work independently while collaborating effectively across diverse cross-functional teams.
- Computer System Validation expertise, German language skills, and Computer System Validation/Data Integrity specialization are considered advantageous.
- Fluency in English is required.
Additional details
- Environmental Conditions
Notes and original content
- Work Schedule
- Standard (Mon-Fri)
- Job Description
- Qualifications:
Questions about this listing
What salary does Thermo Fisher Scientific (Schweiz) AG offer for this role?
Thermo Fisher Scientific (Schweiz) AG lists CHF 85'500 - 129'500 gross per year for this position in Allschwil. This is the salary published in the original listing (or, when the employer omits a figure, a realistic estimate for the role and sector) — the calculator on this site converts it to your actual net take-home once cross-border tax and social contributions are applied.
Is this a full-time role, and what type of contract does Thermo Fisher Scientific (Schweiz) AG offer?
This listing is a full-time position. The contract type shown here comes directly from the employer's original posting; always confirm exact hours, notice period and probation length with Thermo Fisher Scientific (Schweiz) AG during the application process, since these details can vary by role even within the same contract category.
Do I need a cross-border work permit for a role in Basel?
EU/EFTA residents living in the border zone of the country adjoining Canton Basel can apply for a G permit; the Swiss employer files it with that canton's migration office after the contract is signed. Border-zone rules and processing times vary by neighbouring country and canton, so confirm the specifics with Basel's cantonal migration office or with HR during the application.
How do I apply for this position at Thermo Fisher Scientific (Schweiz) AG?
Use the "Apply now" button on this page — it links directly to Thermo Fisher Scientific (Schweiz) AG's original listing at jobs.thermofisher.com, so your application goes straight to the employer's own applicant-tracking system. Frontaliere Ticino does not collect or forward applications itself.
