Novartis Radiopharmaceuticals GmbH
Quality Assurance Officer Operations(m/w/x)
Full-timeWith HomeofficeExperienced
Halle (Saale)
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NONovartis Radiopharmaceuticals GmbH
Process Expert(m/w/x)
Halle (Saale)
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Front-line manufacturing support for compliant batch production at a global pharmaceutical company, driving root cause investigations. 3 years' experience in GMP manufacturing process support or QA/QC shop floor role required. Specific disability support available.
Requirements
- Bachelor's degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience
- 3 years' experience in process support shop floor role in GMP manufacturing and/or QA/QC
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- Strong awareness of quality issues
- Compliance investigations experience
- Excellent technical writing skills
- Fluency in German and English
- Previous Radiopharma experience (a plus)
- Prior leadership and/or high cross-functional experience (preferred)
Tasks
- Provide front-line manufacturing support.
- Ensure safe and compliant batch manufacturing.
- Act as Subject Matter Expert (SME).
- Serve as first point of contact for product and process issues.
- Drive investigations to root cause.
- Implement corrective and preventive actions (CAPAs).
- Manage and maintain Master Batch Records.
- Manage and maintain Standard Operating Procedures (SOPs).
- Manage and maintain risk assessments and protocols.
- Write and review SOPs, batch records, and white papers.
- Collect data for ongoing process verification (OPV).
- Track and evaluate product performance.
- Support CAPA implementation.
- Author and own material transfer investigations.
- Author and own API synthesis investigations.
- Author and own Drug Substance formulation investigations.
- Author and own Drug product filling investigations.
- Author and own inspection and packaging investigations.
- Ensure processes are inspection-ready.
- Support process optimization and new technology introduction.
- Review validation protocols and reports.
- Support execution of process validations.
- Support short-term improvement projects.
- Guide and support production teams.
- Train and share knowledge with production teams.
- Guide processes to closure and completion.
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Other Benefits
- Disability support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Radiopharmaceuticals GmbH 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?
- Novartis Radiopharmaceuticals GmbH
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Ausbildung zum Pharmakanten(m/w/x)
Full-timeApprenticeshipWith HomeofficeHalle (Saale), Jena
NONovartis Radiopharmaceuticals GmbH
Process Expert(m/w/x)
Halle (Saale)
Full-timeWith Home OfficeExperienced
Nejo AI Summary
Front-line manufacturing support for compliant batch production at a global pharmaceutical company, driving root cause investigations. 3 years' experience in GMP manufacturing process support or QA/QC shop floor role required. Specific disability support available.
Requirements
- Bachelor's degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry, or relevant experience
- 3 years' experience in process support shop floor role in GMP manufacturing and/or QA/QC
- Proven process understanding (Pharma, GMP, Regulatory aspects)
- Strong awareness of quality issues
- Compliance investigations experience
- Excellent technical writing skills
- Fluency in German and English
- Previous Radiopharma experience (a plus)
- Prior leadership and/or high cross-functional experience (preferred)
Tasks
- Provide front-line manufacturing support.
- Ensure safe and compliant batch manufacturing.
- Act as Subject Matter Expert (SME).
- Serve as first point of contact for product and process issues.
- Drive investigations to root cause.
- Implement corrective and preventive actions (CAPAs).
- Manage and maintain Master Batch Records.
- Manage and maintain Standard Operating Procedures (SOPs).
- Manage and maintain risk assessments and protocols.
- Write and review SOPs, batch records, and white papers.
- Collect data for ongoing process verification (OPV).
- Track and evaluate product performance.
- Support CAPA implementation.
- Author and own material transfer investigations.
- Author and own API synthesis investigations.
- Author and own Drug Substance formulation investigations.
- Author and own Drug product filling investigations.
- Author and own inspection and packaging investigations.
- Ensure processes are inspection-ready.
- Support process optimization and new technology introduction.
- Review validation protocols and reports.
- Support execution of process validations.
- Support short-term improvement projects.
- Guide and support production teams.
- Train and share knowledge with production teams.
- Guide processes to closure and completion.
Work Experience
- 3 years
Education
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Benefits
Other Benefits
- Disability support
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novartis Radiopharmaceuticals GmbH 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
Novartis Radiopharmaceuticals GmbH
Industry
Pharmaceuticals
Description
Novartis Radiopharmaceuticals GmbH is a manufacturing plant for Radioligand Therapy (RLT) drug products.
Not a perfect match?
- Novartis Radiopharmaceuticals GmbH
Quality Assurance Officer Operations(m/w/x)
Full-timeWith HomeofficeExperiencedHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Quality Assurance Officer Operations(m/w/x)
Full-timeWith HomeofficeExperiencedHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Site Quality Head(m/w/x)
Full-timeWith HomeofficeManagementHalle (Saale) - Novartis Radiopharmaceuticals GmbH
Site Quality Head(m/w/x)
Full-timeWith HomeofficeManagementHalle (Saale) - Wacker Chemie
Ausbildung zum Pharmakanten(m/w/x)
Full-timeApprenticeshipWith HomeofficeHalle (Saale), Jena