Debiopharm
Pharmaceutical Quality (pQM) Specialist(m/w/x)
Full-timeOn-siteExperienced
Lausanne
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FEFerring Pharmaceuticals
QA QMS Senior Specialist(m/w/x)
Saint-Prex
Full-timeOn-siteSenior
Nejo AI Summary
Leading deviation management and self-inspection programs for GMP-regulated pharmaceuticals. Bachelor's or Master's degree in a scientific discipline required. Inclusive support package, parental leave for all parents.
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related scientific discipline
- Proven experience in Quality Assurance and Quality Management Systems within a GMP-regulated pharmaceutical or biotechnology environment
- Strong knowledge of deviation management, self-inspections, CAPA, and inspection readiness activities
- Experience in drafting, reviewing, and approving GMP documentation, procedures, protocols, and quality records
- Ability to train and support cross-functional stakeholders on quality systems and compliance expectations
- Experience participating in Health Authority inspections and/or supplier audits
- Strong analytical skills with ability to trend data, identify compliance risks, and support continuous improvement
- Excellent written and spoken English skills, with ability to draft clear GMP documentation and communicate effectively with cross-functional and international stakeholders
- Experience with Electronic Quality Systems such as TrackWise and Veeva
- Knowledge of Pharmacopoeia regulatory surveillance processes
- Good knowledge of GMP/GxP requirements, quality systems governance, inspection management, root cause analysis, CAPA processes, and quality reporting tools
Tasks
- Ensure effective implementation of QMS processes
- Maintain GMP compliance and operational excellence
- Lead Deviation Management System
- Coordinate self-inspection program
- Plan and analyze self-inspection data
- Report self-inspection findings
- Support self-inspection contributors
- Prepare for Health Authority inspections
- Represent QMS during inspections
- Review and approve quality records
- Review and approve procedures
- Review and approve protocols
- Review and approve reports
- Provide QA oversight for training
- Train new employees on GMP systems
- Train new employees on quality processes
- Support regulatory surveillance
- Review Pharmacopoeias reports
- Improve Pharmacopoeias processes
- Drive continuous improvement initiatives
- Support site GxP compliance
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- TrackWise
- Veeva
Benefits
Other Benefits
- Inclusive support package
Family Support
- Equal and accessible policies for family building
- Extended support on family building journey
Generous Parental Leave
- Parental leave for birthing parents
- Parental leave for non-birthing parents
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ferring Pharmaceuticals 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.
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FEFerring Pharmaceuticals
QA QMS Senior Specialist(m/w/x)
Saint-Prex
Full-timeOn-siteSenior
Nejo AI Summary
Leading deviation management and self-inspection programs for GMP-regulated pharmaceuticals. Bachelor's or Master's degree in a scientific discipline required. Inclusive support package, parental leave for all parents.
Requirements
- Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or related scientific discipline
- Proven experience in Quality Assurance and Quality Management Systems within a GMP-regulated pharmaceutical or biotechnology environment
- Strong knowledge of deviation management, self-inspections, CAPA, and inspection readiness activities
- Experience in drafting, reviewing, and approving GMP documentation, procedures, protocols, and quality records
- Ability to train and support cross-functional stakeholders on quality systems and compliance expectations
- Experience participating in Health Authority inspections and/or supplier audits
- Strong analytical skills with ability to trend data, identify compliance risks, and support continuous improvement
- Excellent written and spoken English skills, with ability to draft clear GMP documentation and communicate effectively with cross-functional and international stakeholders
- Experience with Electronic Quality Systems such as TrackWise and Veeva
- Knowledge of Pharmacopoeia regulatory surveillance processes
- Good knowledge of GMP/GxP requirements, quality systems governance, inspection management, root cause analysis, CAPA processes, and quality reporting tools
Tasks
- Ensure effective implementation of QMS processes
- Maintain GMP compliance and operational excellence
- Lead Deviation Management System
- Coordinate self-inspection program
- Plan and analyze self-inspection data
- Report self-inspection findings
- Support self-inspection contributors
- Prepare for Health Authority inspections
- Represent QMS during inspections
- Review and approve quality records
- Review and approve procedures
- Review and approve protocols
- Review and approve reports
- Provide QA oversight for training
- Train new employees on GMP systems
- Train new employees on quality processes
- Support regulatory surveillance
- Review Pharmacopoeias reports
- Improve Pharmacopoeias processes
- Drive continuous improvement initiatives
- Support site GxP compliance
Work Experience
- approx. 4 - 6 years
Education
- Master's degree
Languages
- English – Business Fluent
Tools & Technologies
- TrackWise
- Veeva
Benefits
Other Benefits
- Inclusive support package
Family Support
- Equal and accessible policies for family building
- Extended support on family building journey
Generous Parental Leave
- Parental leave for birthing parents
- Parental leave for non-birthing parents
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Ferring Pharmaceuticals 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Ferring Pharmaceuticals
Industry
Pharmaceuticals
Description
The company helps people build families and live better lives through scientific advances in reproductive and women's health, gastroenterology, and urology.
Not a perfect match?
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