- Lilly (Indianapolis, IN)
- …and changes, approval of date extension requests and due date changes, approval of process validation protocols and reports, approval of validation master ... of risk-based rationale if bracketing of products is used for cleaning validation , etc.) + Ensure adequate quality oversight for manufacturing operations within… more
- Cognizant (Indianapolis, IN)
- …of software testing strategies * Identification of any remediation effort required on process control software * Create items in the issue tracker as issues arise ... equivalent experience) * 10+ years working Automation experience in the Pharmaceutical Industry (preferable in API/bulk manufacturing) * Previous Pharmaceutical … more
- Novo Nordisk (Bloomington, IN)
- …is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product ... 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee… more
- Lilly (Indianapolis, IN)
- … variability and capability. + Understand, justify, and document the state of validation ( process and cleaning, sterility assurance, etc.) with data that ... that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps. +… more
- Lilly (Indianapolis, IN)
- … variability and capability. * Understand, justify, and document the state of validation ( process and cleaning, sterility assurance, etc.) with data that ... that an accurate instruction set (tickets & procedures) and PFD describe the process as performed and the control strategy for the discrete manufacturing steps. *… more
- Novo Nordisk (Bloomington, IN)
- …cleaning and sanitization, regulatory (worldwide), deviation investigation, product and process validation , environmental testing, and investigations, preferred ... is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product… more
- Novo Nordisk (Bloomington, IN)
- …is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product ... 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee… more
- Lilly (Indianapolis, IN)
- …American contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre- validation / validation , ongoing operations ... to launch new products/ packages/ contract manufacturers (CMs) + Participate on Joint Process Teams + Maintain material management (eg check all API restrictions in… more
- Lilly (Indianapolis, IN)
- …support for Quality Control activities + Experience on equipment qualification, system validation and process validation . + Thorough technical understanding ... and rigorous quality standards. Lilly Manufacturing strives for excellence in its process , standards, procedures and behaviors to develop medicines with safety first… more
- Novo Nordisk (Bloomington, IN)
- …is a state-of-the-art facility where we have an integrated model from process and formulation to clinical and commercial biomanufacturing and drug product ... 6 weeks paid family medical leave + Free access to Novo Nordisk-marketed pharmaceutical products + Tuition Assistance + Life & Disability Insurance + Employee… more