Lonza
life sciences
BatchRecordReviewer(f/m/d)(80100%)
“Batch Record Reviewer (f/m/d) (80-100%) at Lonza. Plan, execute, document manufacturing campaigns. Secure batch safety, timeliness, compliance”
What You'll Achieve.
Securing each batch is manufactured safely, on time, in compliance; timely and with high quality the required production documentation; required timelines; accurate execution
Industry & Context.
Lead process related investigations; critical deviations; decision making on production issues; Use scientific, process and statistical knowledge to analyze data; provide process understanding; identify root causes of product and process failures; dynamic solution-oriented
Prepared to work flexible working hours
What They're Looking For.
Must Have
Bachelor / Master Degree, Fluent in both German and English, Familiarity with GMP requirements, quality procedures, SOP execution, leadership skills, team orientation, Good communication skills, interaction with a variety of interfaces within the organization and on the shopfloor, Structured, focused and well-organized working, open-minded for new ideas and suggestions, High motivation, dynamic solution-oriented, Proven IT knowledge, Prepared to work flexible working hours
Nice to Have
Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree, Experience in Sterile Manufacturing on the shopfloor and/or QC/QA, ERFP (SAP) or MES (Syncade)
What You'll Do.
document manufacturing campaigns
Provide front line technical support
Establish production documentation
Lead process related investigations
Assist in decision making
Support process validation execution
Analyze data for process understanding
Identify root causes of failures
Provide input to Annual Product Reviews
Provide input to Product Quality Review
Provide training for new processes
Act as Subject Matter Expert
Maintain processes at inspection readiness
Prepare and execute SHE risk analysis
Prepare and execute operation risk analysis
Implement and control defined measures
Execute innovation projects
Execute improvement projects
How You'll Work.
Team & Collaboration
working with the manufacturing teams (operators); working with plant engineers; working with QA operations; liaising with all the relevant parties at shopfloor; resource to other departments; interaction with a variety of interfaces within the organization
Communication Scope
Good communication skills
Process & Methodology
planning, execution, documentation, Lead process changes, CAPA effectiveness checks, innovation projects, improvement projects
Applying for this Batch Record Reviewer (f/m/d) (80-100%) role?
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