- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …crucial direction of the Head of Operations and the Head of Quality Systems, the Deviation Investigator will play a pivotal role in our company's growth by ... owning and investigating all Manufacturing-related deviations. The Deviation Investigator will collaborate with cross-functional stakeholders to perform simple… more
- Lilly (Durham, NC)
- …and influence the manufacturing control strategy for their area. + Trained as a Deviation Investigator + Development and monitoring of metrics for the area + ... Aid in issue resolution, batch/product approvals, and production schedule execution. + Lead specific activities of the process teams. **Key Objectives/Deliverables:** **Requirements (Education, Experience, Training):** + High School Diploma or equivalent +… more
- Actalent (Winston Salem, NC)
- …all team members comply with safety rules and regulations. The Technical Investigator is responsible for the initiation, investigation and completion of process ... of Root Cause Analysis to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety, Identity, Strength, Quality,… more
- Lilly (Concord, NC)
- …area deviation and corrective action discussions as a lead investigator with a cross-functional team from Engineering, Maintenance, Technical Services / ... methodologies and mindset - lean, six sigma, etc. + Documentation, deviation and change management systems (eg, Trackwise. Veeva QualityDocs, Kneat) **Additional… more
- ThermoFisher Scientific (Wilmington, NC)
- …Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of ... committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications + Ensure...to questions from sites /IRBs RAs, eligibility and protocol deviation decisions will be harmonized across medics **Keys to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the Pharmaceutical Industry. This role is mainly responsible for completing deviation investigations, OOS/OOT and CAPA development related to EM and microbiological ... on updating SOPs, WIs, and OJT + Complete and maintain certified investigator training requirements. Perform investigation of the quality events assigned using root… more
- Lilly (Concord, NC)
- …solving skills by leading equipment failures troubleshooting, demonstrating RCA lead investigator proficiency and guide operations personnel in the resolution of ... and computerized maintenance management systems (CMMS) + Previous experience with deviation and change management systems including Trackwise Lilly is dedicated to… more
- Fujifilm (Holly Springs, NC)
- …site, as we enter commercial manufacturing. The span of work supports Deviation Management and Corrective Actions across all Drug Substance Manufacturing areas from ... deviations for the functional areas + Assist in the creation of Investigator onboarding documents + Create and maintain a centralized Manufacturing knowledge… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …of the annual audit plan using risk-based approaches. + Coordinate and support investigator site, vendor, and internal process audits. + Track audit findings and ... improvement of clinical quality systems, SOPs, and policies. + Assist with deviation management, root cause analysis, and CAPA tracking related to clinical… more
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