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QA Deviation Management Specialist(m/w/x)
Reviewing and approving deviations, complaint investigations, and CAPAs for clinical trial supply solutions. Minimum 2 years of deviation investigation and QMS experience required. Mentoring investigators and ensuring cGMP compliance.
Requirements
- Degree or relevant experience in pharmaceutical industry, QC/QA, medication handling, life sciences, or related scientific field
- Preferred study fields: Biology, Chemistry, Engineering, Life Sciences, or equivalent
- Knowledge of cGMP regulations and/or international regulatory requirements
- Minimum 2 years experience in deviation investigations, CAPA, change control, root cause analysis
- Minimum 2 years experience with quality management systems and documentation (e.g., TrackWise or equivalent)
- German B2 or higher, English B2 or higher
- Experience delivering training sessions
- Excellent communication and organizational skills
- High accuracy, accountability, and efficiency
- Ability to work independently and collaboratively in cross-functional teams
- Ability to manage priorities and meet timelines
Tasks
- Review and approve deviations
- Review and approve complaint investigations
- Review and approve CAPAs
- Review and approve effectiveness checks
- Mentor investigators to improve investigation quality
- Mentor investigators to improve CAPA quality
- Coordinate investigation approvals within timelines
- Support batch release activities
- Analyze data to improve Quality KPIs
- Participate in Practical Process Improvement initiatives
- Support quality and efficiency projects
- Provide support to the broader Quality organization
- Support internal audits
- Support client audits
- Support regulatory inspections
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- TrackWise
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QA Deviation Management Specialist(m/w/x)
Reviewing and approving deviations, complaint investigations, and CAPAs for clinical trial supply solutions. Minimum 2 years of deviation investigation and QMS experience required. Mentoring investigators and ensuring cGMP compliance.
Requirements
- Degree or relevant experience in pharmaceutical industry, QC/QA, medication handling, life sciences, or related scientific field
- Preferred study fields: Biology, Chemistry, Engineering, Life Sciences, or equivalent
- Knowledge of cGMP regulations and/or international regulatory requirements
- Minimum 2 years experience in deviation investigations, CAPA, change control, root cause analysis
- Minimum 2 years experience with quality management systems and documentation (e.g., TrackWise or equivalent)
- German B2 or higher, English B2 or higher
- Experience delivering training sessions
- Excellent communication and organizational skills
- High accuracy, accountability, and efficiency
- Ability to work independently and collaboratively in cross-functional teams
- Ability to manage priorities and meet timelines
Tasks
- Review and approve deviations
- Review and approve complaint investigations
- Review and approve CAPAs
- Review and approve effectiveness checks
- Mentor investigators to improve investigation quality
- Mentor investigators to improve CAPA quality
- Coordinate investigation approvals within timelines
- Support batch release activities
- Analyze data to improve Quality KPIs
- Participate in Practical Process Improvement initiatives
- Support quality and efficiency projects
- Provide support to the broader Quality organization
- Support internal audits
- Support client audits
- Support regulatory inspections
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- TrackWise
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
Fisher Clinical Services GmbH
Industry
Pharmaceuticals
Description
Das Unternehmen ist marktführend in den Bereichen Clinical Supply Chain Management Services und Clinical Supplies für Patienten weltweit.
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