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16333en
- Contract
- English, German
- Associate
- Engineering & Technical Services
- Switzerland
- Healthcare & Life Sciences
Skills
batch record review, deviation review, CRs, TCRs, QA, GDP, GMP, DeltaV, MES Syncade, Chargenprotokollprüfung, Abweichungsprüfung, CRs, TCRs, QA, GDP, GMP, DeltaV, MES Syncade
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This vacancy has now expired
On behalf of our client, a leading international biotechnology company, Swisslinx is looking for a Batch Record Reviewer and Support Specialist. In this role, you will ensure the accuracy and compliance of critical batch records in a fast-paced, GMP-regulated environment, collaborating closely with operations and QA teams to drive smooth and efficient product release.
Contract type – Contract
Start Date – November
Location – Visp
Workload – 100%
Duration – initiall 6 months (until May 2025)
Your Mission:
• Review of the executed electronic Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)
• Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
• Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations
• Support the initiation of CRs and TCRs
• Support preparation of documentation package to enable fast release by QA
Your Background:
• Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
• Ability to identify non-compliance and gaps from quality standards
• Very good communication skills and interaction with all kinds of interfaces within the organization; 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
• Ability to produce reliable results under stress
• Knowledge of MES Syncade, DeltaV system (preferably)
• Fluent in English (German basic knowledge is an advantage)
What's on offer
• An initially 6 month contract.
• A great opportunity to develop your career at a leading international biotechnology company.
• A competitive salary.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
Contract type – Contract
Start Date – November
Location – Visp
Workload – 100%
Duration – initiall 6 months (until May 2025)
Your Mission:
• Review of the executed electronic Batch Records (e.g. cleaning logs, production documentation review, temperature reports, test procedures (HEPT, FIT), Autoclave and Washing machine protocols, used material, calibration records, sample results recorded in LIMS, logbooks, etc.)
• Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
• Initiate and support accomplishment of Deviations and investigations for Batch Record review related observations
• Support the initiation of CRs and TCRs
• Support preparation of documentation package to enable fast release by QA
Your Background:
• Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
• Ability to identify non-compliance and gaps from quality standards
• Very good communication skills and interaction with all kinds of interfaces within the organization; 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
• Ability to produce reliable results under stress
• Knowledge of MES Syncade, DeltaV system (preferably)
• Fluent in English (German basic knowledge is an advantage)
What's on offer
• An initially 6 month contract.
• A great opportunity to develop your career at a leading international biotechnology company.
• A competitive salary.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
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