摘要
About the Role
Responsibilities:
- Authors manufacturing investigations and meets all targets for timely closure and CAPA completion.
- Supports steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
- Performs first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
- Provides and supports assessments of technical changes, establishment of root-cause analysis, Quality Risk Assessment and process control strategies.
- Supports process optimization establishment and new technology introduction for continued productivity improvement, as appropriate.
- Supports the execution of process validations, and short-term improvement projects, collaborating with all the relevant parties at shop floor to ensure accurate execution. Launch & Transfer– for the product(s) assigned.
- Revises the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Hazard Analysis).
- Ensures creation of production SOPs and revisions to Master Batch Records and/or Electronic Records.
- Maintain processes at inspection readiness level.
- Ensures that all critical parameters are within written Instruction (e.g. Master Batch Record, Quality Risk Assessment, and Validation Protocol).
- Supports data collection for ongoing process verification, support manufacturing lead in tracking and evaluation of product performance and implementation of CAPAs.
- Reviews protocols and reports for technical correctness.
- Other related duties as assigned.
Requirements:
- Bachelor’s degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 2 years of work experience in biopharmaceutical based GMP manufacturing operations.
- Master’s degree in Engineering, Biology, Chemistry, Biotechnology, or applicable field and 1 year of work experience in biopharmaceutical based GMP manufacturing operations.
- Fluent in English. Excellent oral and written communication skills. Strong technical writing ability required.
- Travel, as required, to other internal sites (<10%).
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Accessibility and accommodation
Novartis is committed to work with and provide reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
