Rahul Oliver, Mbt, Cqe, Cqa Email & Phone Number

Bloomington, Indiana, United States

Bagsværd, Dk

Lead the Drug Product Formulation and Filling Quality Organization and build a Sterility Assurance department at Catalent Indiana LLC, part of Novo Nordisk (since December 2024) to ensure patient and business needs are met in a dynamic CDMO space.

Melbourne, Victoria, Au

Provide strategic and tactical leadership and Quality Oversight to aseptic filling operations including inspection and Packaging. Build, manage, and grow quality on the floor operations. Site Quality Representative for multiple global initiatives including Annex I assessment and fulfillment, isolator management and usage and CMO sterility assurance subject matter expert. Wins include directly improving compliance standing, multiple successful Regulatory Inspections, promotion of high performers, supporting technology transfer, approval of first gene therapy product for CSL, and growth as a professional.

New York, New York, Us

Provide leadership and quality guidance for multiple value streams (Sterile Liquid Products and Sterile Syringe Focus Factory) with responsibility for support and oversight of manufacturing shop floor quality (aseptic fill lines, visual inspection, and packaging), sterility assurance, quality risk management, deviation management and associated batch disposition, and people development; Lead cross functional collaboration efforts for better integration with Operations and global partners to ensure product supply to patients and continuous process improvement.

Lakewood, Colorado, Us

Member of a core team providing leadership and responsible for process design and deployment of a global transformational electronically enabled Quality Management System (QMS); Primary area of influence toward global policy development and process design for Corrective Action/Preventative Action, Non-conformance, and Trend Code Management with inputs from Design Controls and Risk Management to be in compliant with ISO 13485 and Regulatory Requirements for Medical Device and Combination Products; High involvement with cross-functional, multicultural, and international teams for QMS deployment and User Requirement development

Summit, New Jersey, Us

Provide floor level supervision and manage quality assurance operations team over three shifts ensuring meeting product release dates, performance of Manufacturing Quality Audits on finished product, timely completion of all tasks, meeting department/site objectives, and providing QA oversight for aseptic manufacturing of sterile product (Lyophilized Product Value Stream). Responsible to Review/Approve of Deviations, Change Control, Trends, Technical Protocols, SOPs, Stability Data, QC Release Testing, and Validation Protocols to sustain compliance, support critical projects, and ensure product quality. Accountable to review batch record and issued final batch disposition recommendation for multiple markets to ensure global supply to patients. Supported multiple Regulatory Health Agency Inspections; Qualified visual inspector on manual inspection method for finished product.

Foster City, Ca, Us

Lead and support multiple elements of the Quality system resulting in being recognized as a subject matter expert (SME) interacting directly with Inspectors during Regulatory Health Inspections and Customer Audits; Managed/Supervised Site Complaint and Corrective/Preventative Action Business Processes; Core member of the Deviation Business process leading quality risk assessments, authoring and defending critical level deviations, and training other team members. Served as Compliance Officer for the Site— member of cross-functional team responsible for development of metrics, Trend Analysis on GMP Metrics on a Quarterly basis, and presented metrics to Senior Management Team and proposed strategic solutions for at risk processes. Supported Internal Audit program, providing oversight on Aseptic Behavior, aligning with procedures, gap assessment, and data analysis. Participated in external audit program as an SME. Design, develop, and conduct site training in order to meet regulatory compliance, enhance team building, improve key performance indicators, and facilitate professional development of colleagues.

Los Angeles, Ca, Us

Successfully transferred manual method for bio-banking and Genomic Sequencing to a high- throughput automated method leading to increase in laboratory capabilities Developed Pilot Validation Methods for Effluent Waste System (Infectious Disease) , Tecan Accessioning System, and Pass-thru Autoclave using both molecular and microbiology platforms. Supported Laboratory Commissioning through instrument/equipment qualification, developing work process flow, training, and addressing bio-safety challenges for BioSafety level 3 laboratory; Serve as Automation Lead responsible for development of automated methods, training technicians and operators leading to standardize practices

Foster City, Ca, Us

Dublin, Coolock, Ie

Mclean, Virginia, Us

Prior to February 2008 with Public Health Foundation Enterprises.

Phoenix, Az, Us

Tempe, Az, Us

Phoenix, Arizona, Us

Alexandria, Va, Us

Bs, Chemical Engineering

Master'S Degree, Biotechnology

Chemical Engineering And Molecular Biology