Lonza
Senior QA Specialist, QA Operations(m/w/x)
Full-timeOn-siteSenior
Visp
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QA support for manufacturing, cleaning, environmental monitoring at a pharma/biotech strategic partner, witnessing critical GMP steps and in-process controls. Strong QA background in pharmaceutical manufacturing with solid GMP understanding and aseptic process knowledge required. Competitive pension fund plan, annual bonus.
Requirements
- Strong background in quality assurance (pharmaceutical/regulated manufacturing) with solid GMP understanding
- Good understanding of aseptic process and its core requirements
- Excellent communication and coaching skills
- Ability to make sound decisions and manage deviations
- Collaborative spirit and passion for compliance/product integrity
Tasks
- Provide quality assurance support during manufacturing, cleaning, and environmental monitoring
- Monitor GMP adherence during critical manufacturing steps
- Witness and verify critical process steps
- Witness and verify in-process controls (IPCs)
- Witness and verify reconciliations
- Perform and document line clearances before manufacturing
- Review manufacturing processes for batch record and SOP compliance
- Ensure proper material handling, labeling, and segregation during production
- Identify and report shop floor deviations or abnormal events
- Support or lead immediate impact assessment of deviations
- Document on-the-floor deviations
- Escalate issues to QA and production leadership
- Coordinate with QA and production leadership for resolution
- Review batch manufacturing records for accuracy, completeness, and compliance
- Ensure timely corrections to documentation issues
- Assist operators with proper GMP documentation practices
- Verify shop floor logbooks, equipment use records, and cleaning records
- Observe and assess aseptic interventions for technique and contamination control
- Support environmental monitoring, gowning practices, and cleanroom behavior compliance
- Conduct routine walkthroughs and spot checks for GMP compliance
- Participate in internal audits and regulatory inspections
- Provide on-the-floor knowledge and documentation during audits
- Provide on-the-job coaching and GMP guidance to staff
- Reinforce good documentation practices (GDP)
- Reinforce quality culture
- Provide input for root cause analysis based on observations
- Support CAPA implementation and follow-up
- Address CAPAs directly related to shop floor findings
Work Experience
approx. 1 - 4 years
Education
Bachelor's degreeORMaster's degree
Languages
English – Business Fluent
Benefits
Retirement Plans
- •Competitive pension fund plan
Bonuses & Incentives
- •Annual bonus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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?
- Lonza
Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
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Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Full-timeOn-siteSeniorVisp
QA support for manufacturing, cleaning, environmental monitoring at a pharma/biotech strategic partner, witnessing critical GMP steps and in-process controls. Strong QA background in pharmaceutical manufacturing with solid GMP understanding and aseptic process knowledge required. Competitive pension fund plan, annual bonus.
Requirements
- Strong background in quality assurance (pharmaceutical/regulated manufacturing) with solid GMP understanding
- Good understanding of aseptic process and its core requirements
- Excellent communication and coaching skills
- Ability to make sound decisions and manage deviations
- Collaborative spirit and passion for compliance/product integrity
Tasks
- Provide quality assurance support during manufacturing, cleaning, and environmental monitoring
- Monitor GMP adherence during critical manufacturing steps
- Witness and verify critical process steps
- Witness and verify in-process controls (IPCs)
- Witness and verify reconciliations
- Perform and document line clearances before manufacturing
- Review manufacturing processes for batch record and SOP compliance
- Ensure proper material handling, labeling, and segregation during production
- Identify and report shop floor deviations or abnormal events
- Support or lead immediate impact assessment of deviations
- Document on-the-floor deviations
- Escalate issues to QA and production leadership
- Coordinate with QA and production leadership for resolution
- Review batch manufacturing records for accuracy, completeness, and compliance
- Ensure timely corrections to documentation issues
- Assist operators with proper GMP documentation practices
- Verify shop floor logbooks, equipment use records, and cleaning records
- Observe and assess aseptic interventions for technique and contamination control
- Support environmental monitoring, gowning practices, and cleanroom behavior compliance
- Conduct routine walkthroughs and spot checks for GMP compliance
- Participate in internal audits and regulatory inspections
- Provide on-the-floor knowledge and documentation during audits
- Provide on-the-job coaching and GMP guidance to staff
- Reinforce good documentation practices (GDP)
- Reinforce quality culture
- Provide input for root cause analysis based on observations
- Support CAPA implementation and follow-up
- Address CAPAs directly related to shop floor findings
Work Experience
approx. 1 - 4 years
Education
Bachelor's degreeORMaster's degree
Languages
English – Business Fluent
Benefits
Retirement Plans
- •Competitive pension fund plan
Bonuses & Incentives
- •Annual bonus
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of ten23 health 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
ten23 health
Industry
Pharmaceuticals
Description
The company is a human-centric strategic partner for the pharmaceutical industry and biotech start-ups, focusing on the development and testing of medicines.
Not a perfect match?
- Lonza
Senior QA Specialist, QA Operations(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Head of QA Support (Shop Floor and Batch Record Review)(m/w/x)
Full-timeOn-siteManagementVisp - CH12 Lonza AG
Senior QA Specialist(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Senior QA Specialist/QA Project Manager(m/w/x)
Full-timeOn-siteSeniorVisp - Lonza
Senior QA Specialist - Qualification/Validation/EM (Environmental Monitoring)(m/w/x)
Full-timeOn-siteSeniorVisp