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Batch Record Review and Support Specialist(m/w/x)
Reviewing electronic batch records for biological product manufacturing. Experience in GMP/GDP regulated pharmaceutical industry preferred. Agile career path, dynamic working culture.
Requirements
- Previous experience in GDP and GMP regulated pharmaceutical/API industry
- Experience in batch record review (preferred eBR) or manufacturing
- Ability to identify non-compliance and gaps from quality standards
- Very good communication and interaction skills
- Strong team orientation
- Structured, focused, and well-organized working attitude
- Open-minded for new ideas and suggestions
- Solution-oriented
- Agile, highly motivated, and dynamic drive
Tasks
- Review executed electronic batch records independently and on time
- Ensure operations batch records are accurately executed
- Confirm batch records are complete for QA review
- Collaborate with Manufacturing and Quality teams
- Clarify documentation issues with teams
- Resolve documentation issues with teams
- Initiate Quality Records for batch record observations
- Support management of Quality Records for batch record observations
- Support preparation of documentation packages
- Enable fast release by QA
Work Experience
- approx. 1 - 4 years
Education
- High school diploma
Languages
- English – Business Fluent
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
- Inclusive workplace
Purpose-Driven Work
- Ethical workplace
Bonuses & Incentives
- Performance-based compensation
Not a perfect match?
- LonzaFull-timeOn-siteJuniorVisp
- Lonza
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Batch Record Review and Support Specialist(m/w/x)
Reviewing electronic batch records for biological product manufacturing. Experience in GMP/GDP regulated pharmaceutical industry preferred. Agile career path, dynamic working culture.
Requirements
- Previous experience in GDP and GMP regulated pharmaceutical/API industry
- Experience in batch record review (preferred eBR) or manufacturing
- Ability to identify non-compliance and gaps from quality standards
- Very good communication and interaction skills
- Strong team orientation
- Structured, focused, and well-organized working attitude
- Open-minded for new ideas and suggestions
- Solution-oriented
- Agile, highly motivated, and dynamic drive
Tasks
- Review executed electronic batch records independently and on time
- Ensure operations batch records are accurately executed
- Confirm batch records are complete for QA review
- Collaborate with Manufacturing and Quality teams
- Clarify documentation issues with teams
- Resolve documentation issues with teams
- Initiate Quality Records for batch record observations
- Support management of Quality Records for batch record observations
- Support preparation of documentation packages
- Enable fast release by QA
Work Experience
- approx. 1 - 4 years
Education
- High school diploma
Languages
- English – Business Fluent
Benefits
Career Advancement
- Agile career
Informal Culture
- Dynamic working culture
- Inclusive workplace
Purpose-Driven Work
- Ethical workplace
Bonuses & Incentives
- Performance-based compensation
About the Company
Lonza
Industry
Pharmaceuticals
Description
Lonza is a global leader in life sciences, committed to improving lives through innovative solutions and ethical practices.
Not a perfect match?
- Lonza
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