Dragan Gicev Email & Phone Number

Columbus, Oh, Us

New Albany, Ohio, United States

Document control specialist and technical writer for internal documents in manufacturing of sterile injectables.

New Albany ,Ohio

Quality assurance in operations; including labeling, packaging, aseptic filling and compounding of pharmaceutical sterile injectables. Effectively applies knowledge of GMPs, regulations, procedures in real time and guidance documents to daily activities. Provide resolution of quality issues, including deviations, memos, investigations, and CAPAs.• Perform Accepted Quality Level (AQL) inspections on (manually and automatic) inspected filled vials, packaged finished product and incoming component materials.• Monitoring quality processes as per batch record and SOPs.• Reviewing and recommending critical quality processes on current SOPs. • In real time Batch record review and impact statements.• DEA compliance officer.• Performing operation’s line clearances and challenges. • Evaluates Batch records and SOP gaps, providing continuous improvements through change management (Veeva and TrackWise).• Identifies process and procedure gaps, reports, escalates issues, and developscorrective actions.• Provides on-the-floor guidance and support on documentation, annotations and memosto QA Operations Associates and production Operators• Resolves quality issues, in conjunction with QA management as necessary,including deviations, memos, investigations, and CAPAs.• Identifies out-of-specification product, ensuring segregation and escalation, as required• Partners with operations to resolve errors and/or discrepancies, ensuring resolution of errors and omissions. • Partners with Validation in developing and executing equipment and methodOQ/PQ.• Conducting Investigations and interviews for unplanned deviations.• Generates and reviews and statistical control charts.• Generate and Review transportation TempTales reports.

Columbus Ohio

Analyze reactor's in process samples, final product and for resale samples. Evaluating, identifying and quantifying chemical compounds and solvents including; Fine Organics (aldehydes, alcohols, ketones, amines, dyes, Stains and Indicators and halogenated compounds), Specialty Olefins, Acetylenes, Silyl Intermediates, Phase Transfer Catalysts, Heteroaromatic Ligands, and Grignard Reagents.• Technologies used: GC-FID, GC-MS, HPLC, PH, Flash Point, KF titration and FTIR.• Inventory management, storage, handling labeling and 5S.• Audit and process improvements , • Author and reviewer on SOPs and Work instructions.• Manufacturing and packaging of GMP medical device product.• Small batch distillation purifications.

Columbus, Ohio Area

Quality testing for bulk, starting materials, packaged and stability products for Spiriva, Micronized Lactose/Tiotropium, Atrovent HFA ,Nasal Sprays according to internal specifications, USP, EP, and JP guidelines TECHNICAL QUALITY Analytical chemistry and physical properties testing of a bulk, starting materials API’s , finished packaged products, and costumer complaintsInstall, validate and calibrate new laboratory equipmentAuthor and reviewer for internal work instructions documents INVESTIGATIONAL Prepare for FDA audits and other international inspectionsEfficiently identify the root causes during investigation of laboratory testing of various productsSustain high standards to conform with CAPA mindsetForesee and identify problems and provide feedback for preventative and corrective actionProactively evaluate current practices for safety and efficiencyCOMMUNICATIONTrain, mentor, and provide technical support to colleagues on certifications and techniques specific for Flow 5 and GxA quality labRepresent QC at job board meetings to communicate status updates throughout the Flow to ensure effective and efficient planningEquipment Specialization: Karl Fischer Oven with Tiamo 2.1, HIAC Royco Operation PharmSpec Software version 2.0, Metrohm’s Karl Fischer Oven, TAM III calorimeter, Sympatec particle size, HPLC systems, Anderson Cascade Impactor.Laboratory Certifications: HPLC, Uniformity of Delivered Dose and Content Uniformity, Active Ingredient Content, Aerodynamic Fine Particle Dose with Anderson Impactors, Particulate Contamination by Laser Diffraction (HIAC), Sympatec Particle Size and QICPIC, Karl Fisher\Oven, Enthalpy with Thermal Activity Monitor, Thin Layer Chromatography, Liquid Extractions, FTIR and Microscopy.

Blacklick , Ohio

Server, banquet server, bartender