1201 F. Hoffmann-La Roche AG
GMP Compliance Specialist(m/w/x)
Full-timeOn-siteExperienced
Basel
New Job?Nejo!
Your personal AI career agent
THThermo Fisher Scientific
Operation Investigation Management Specialist(m/w/x)
Allschwil
Full-timeOn-siteExperienced
Nejo AI Summary
Investigating deviations and CAPA for GMP compliance in pharmaceutical manufacturing. Advanced degree or 2 years experience in a regulated biotech environment required. Support for manufacturing operations, cross-functional collaboration.
Requirements
- Advanced degree or Bachelor's degree with 2 years experience in pharmaceutical/biotech manufacturing, quality assurance, or GMP environment
- Preferred study fields: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
- Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent)
- Experience in deviation investigations, CAPA, change control, and root cause analysis
- Proficiency in Microsoft Office suite and quality management software systems
- Technical writing and documentation skills
- Analytical and problem-solving abilities
- Clear verbal and written communication skills
- Ability to work independently and collaboratively in cross-functional teams
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Ability to work in cleanroom environments and follow gowning procedures
- Additional language skills beneficial
- Fluent English and conversational German (B2)
Tasks
- Ensure compliance with GMP standards
- Adhere to FDA regulations
- Meet international quality requirements
- Support manufacturing operations
- Collaborate with cross-functional teams
- Implement continuous improvement initiatives
- Conduct investigations
- Maintain quality management systems
- Contribute to global healthcare
- Advance scientific goals
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Fluent
- German – Business Fluent
Tools & Technologies
- TrackWise
- Master Control
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
Not a perfect match?
- 1201 F. Hoffmann-La Roche AG
QC Investigator(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - F. Hoffmann-La Roche AG
Complaint Lead Investigator(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Roche
GMP Prozess Experte kommerzielle Pharmaproduktion(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Full-timeOn-siteSeniorBasel
THThermo Fisher Scientific
Operation Investigation Management Specialist(m/w/x)
Allschwil
Full-timeOn-siteExperienced
Nejo AI Summary
Investigating deviations and CAPA for GMP compliance in pharmaceutical manufacturing. Advanced degree or 2 years experience in a regulated biotech environment required. Support for manufacturing operations, cross-functional collaboration.
Requirements
- Advanced degree or Bachelor's degree with 2 years experience in pharmaceutical/biotech manufacturing, quality assurance, or GMP environment
- Preferred study fields: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
- Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
- Experience with quality management systems and documentation (TrackWise, Master Control, or equivalent)
- Experience in deviation investigations, CAPA, change control, and root cause analysis
- Proficiency in Microsoft Office suite and quality management software systems
- Technical writing and documentation skills
- Analytical and problem-solving abilities
- Clear verbal and written communication skills
- Ability to work independently and collaboratively in cross-functional teams
- Experience conducting internal audits and supporting external regulatory inspections
- Project management and organizational skills
- Ability to work in cleanroom environments and follow gowning procedures
- Additional language skills beneficial
- Fluent English and conversational German (B2)
Tasks
- Ensure compliance with GMP standards
- Adhere to FDA regulations
- Meet international quality requirements
- Support manufacturing operations
- Collaborate with cross-functional teams
- Implement continuous improvement initiatives
- Conduct investigations
- Maintain quality management systems
- Contribute to global healthcare
- Advance scientific goals
Work Experience
- 2 years
Education
- Master's degree
Languages
- English – Fluent
- German – Business Fluent
Tools & Technologies
- TrackWise
- Master Control
- Microsoft Office
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Thermo Fisher Scientific
Industry
Healthcare
Description
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Not a perfect match?
- 1201 F. Hoffmann-La Roche AG
GMP Compliance Specialist(m/w/x)
Full-timeOn-siteExperiencedBasel - 1201 F. Hoffmann-La Roche AG
QC Investigator(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - F. Hoffmann-La Roche AG
Complaint Lead Investigator(m/w/x)
Full-timeOn-siteSeniorKaiseraugst - Roche
GMP Prozess Experte kommerzielle Pharmaproduktion(m/w/x)
Full-timeOn-siteExperiencedKaiseraugst - 1201 F. Hoffmann-La Roche AG
QA Manager IT/OT(m/w/x)
Full-timeOn-siteSeniorBasel