Nikki Viola Email & Phone Number

Bergisch Gladbach, North Rhine-Westphalia, DE

• Manage two clients and their processes as QA SME-- autologous drug product for Miltenyi Biotec and allogeneic drug product for an external client
• Provides QA oversight on process SOPs, BPRs, WIs for Manufacturing and QC department
• Provides QA compliance oversight for open quality records ie. Deviations, OOS, CAPAs and Change Controls
• Review and approve BPRs, QC SOPs, QC Assay worksheets and Final Drug Product Specifications prior to execution in cleanroom
• Review and approve client protocols including but not limited to APS, PQ, and Long-Term Stability Studies
• Disposition APS, PQ and Clinical lots (i.e. Review of Certificate of Analysis, Certificate of Conformance, BSE TSE statements, initiate Disposition forms which reviews related quality events that transpired within.

Bergisch Gladbach, North Rhine-Westphalia, DE

~Review of executed batch records, QC data packets, Environmental Monitoring packets, and contract lab Certificate of Analysis, and deviation reports~Inspect, review and disposition of raw materials, reagents, and components for GMP use~Conduct manufacutring line clearances, in-process raw material inspections, support final product ship out~Review.

Ingelheim Am Rhein, Rhineland-Palatinate, DE

~Coordinate day-to-day operations within lab to ensure raw materials are sampled, aliquoted and distributed to contract labs or in-house labs~Ensure raw material release timelines are met by coordinating multiple tests performed at contract laboratories and in-house labs~Review raw material lot packets-receipt documentation from the Logistics team to.

Ingelheim Am Rhein, Rhineland-Palatinate, DE

~Perform inspection and sampling of raw materials in accordance to cGXP, AQL~Verification of Quality Certificates (analysis, irradiation, quality, etc)~Perform SAP Production transactions for material information and status~LIMS knowledge for creating labels, process information, distribution of samples, and tracking raw material samples~Experienced with.

South San Francisco, California, US

~Operate CIP an dSIP automated systems for mobile and immobile industrial sized tanks~Clean by sterilization of glassware, hoses, pumps and other parts in the manufacturing floor~Formulation of buffer batches thru MES and SOPs~Standardize and calibrate pH and conductivity meters~Knowledge of aseptic techniques in isolation purification floor, and final.