Production Quality Manager
vor 1 Woche
Key responsibilities:
- Review of the executed 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.)
- Prepare a complete documentation package to enable fast release by QA
- Review comments added to the executed Batch Records, clarify with the operations team and evaluate with the responsible QA Manager
- Lead the initiation and accomplishment of Deviations and investigations for Batch Record review related observations
- Lead the initiation of CAPAs out of relevant Deviations
- Lead the eBRs review process to assure and respecting correct due dates
- Lead deviation and CAPAs process
- Collect and evaluate KPI data on a regular basis
- Managing and approval CRs and TCRs and corresponding CAPEX projects
- Write and revise SOPs in his/her area of expertise
- Support presentation and documentation of department specific activities in audits and inspections
Key requirements:
- University degree in Chemistry, Chemical Engineering, Biotechnology, Bioengineering or related disciplines
- Previous experience in GDP and GMP regulated pharmaceutical / API industry is an advantage
- Ability to identify noncompliance 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 wellorganized working attitude
- Openminded for new ideas and suggestions; solutionoriented
- Agile, highly motivated and dynamic drive
- Ability to produce reliable results under stress
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences.
Reference:
R49527:
- Apply
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