Bella P. Email & Phone Number

Sussex, Nj, Us

Sussex, Nj, Us

Binzen, Baden-Württemberg, De

Technical Specialist-Validation​▪ Creates, reviews and manages the generation of technical documents in support of Pharmaceutical Development, Operations, Technical Operations, Process Validation, Cleaning Validation and Equipment Qualification activities ensuring compliance with 21CFR, Parts 11, 210, & 211.▪ Creates and reviews Cleaning Validation Protocols/Reports, Executive Qualification Summary Reports, GMP Equipment Risk Assessments, IQ/OQ/PQ documents, and commissioning documents.▪ Creates and Manages the Processing Equipment Master List in MS Access Database.▪ Creates and completes Change Controls in MS Access Database.▪ Reviews Change Controls, Deviations, Investigations, CAPA’s, Work Orders, Equipment PreventiveMaintenance and Calibrations for the purpose of creating GMP Equipment Risk Assessments forprocessing equipment as well as QC Instrumentation.▪ Performs Cleaning Validation equipment swabbing and creates Samples Request Forms for analyticaltesting of the swabs, using Access Database.▪ Performs Computer Systems Validation (CSV) by reviewing and executing Software IOPQ Protocolsin MS Access.▪ Reviews/updates Validation Master Plan and Cleaning Validation Master Plan.▪ Reviews/updates divisional/departmental SOPs, including accompanying forms and attachments,though Change Controls.▪ Reviews Master Batch Record (MBR) data in support of reviewing Process Validation Reports.▪ Researches new equipment through user manuals and creates IQ/OQ/PQ documents for theequipment qualification program.▪ Performs Laboratory Walkthroughs and reviews QC Validation reports in support of QC Department.▪ Assisted in Drug Safety Labeling review

Binzen, Baden-Württemberg, De

•Performs ongoing reviews to ensure compliance, accuracy and completeness of all relevant data, notebooks, logbooks, etc. as well as audits the laboratory, per GLPs, cGMPs, and SOPs, TMs, Stability Protocols, Validation Reports and current USP. Reviews Audit Trails, calibration and usage logs on cGMP instrumentation and equipment. •Recognizes deviations from normal results, informs management of any OOS results/deviations that may affect integrity of data. Suggests further corrective action or further investigation to remediate such results. Writes and reviews laboratory Investigation Reports. •Creates and reviews Analytical Release Reports and Stability Summary Reports. •Works with analysts to correct errors and omissions in documentation. •Conducts routine QC and non-routine R&D analytical testing such as Assay, Content Uniformity, Impurities/ Related Substances, Dissolution, moisture analysis using Karl Fischer Titrator, and Particle Size Distribution analysis (PSD) on solid dosage forms, to support multiple projects such as QC release of drug products, API’s, controlled substances, intermediates and excipients, and stability studies in conformance with company SOPs, test methods, protocols, USP monographs, and ICH guidelines. •Operates HPLC utilizing Empower chromatographic analysis and processing software. Performs dissolution as per current USP. •Conducts Method Validation/Verification and contributes to pharmaceutical method development; conducts Process Validation and performs Cleaning Validation. •Calibrates instruments daily before use and conducts troubleshooting. •Documents and maintains complete records of analysis in laboratory notebooks and worksheets in compliance with cGMPs. Creates analytical reports for release and stability, writes Method Validation Reports, creates Change Controls and updates Test Methods. •Trains staff and new hires on testing techniques and cGMPs documentation practices.

Woodcliff Lake, New Jersey, Us

• Performing diversified chemical testing techniques on incoming raw chemicals, components, intermediate bulk liquids, and finished goods, using current USP, SOPs, Work Instructions (WIs), GLPs, GMPs, in house test methods, and customer supplied test methods • Assuring that tested materials have met the required specification criteria prior to release, or if not, taking appropriate action to rectify the matter• Maintaining accurate, complete and traceable documentation related to analysis and disposition• Training other analysts in various techniques and test methods • Performing Cleaning Validation on various machines and tanks on the production floor, testing for residual cleaning agents by swabbing the surfaces then analyzing the rinsate• Managing the inventory of the monthly reference standards to make sure they are up to date and in stock• General maintenance, trouble shooting, and calibration of laboratory equipment, instruments and their reagents • Performed monthly calibration of the inline blending FT-NIR and tested a sample to compare the result similarity to GC• Assisting in Method Development and Validation for new FT-NIR methods•Skilled in Microsoft Office - Microsoft Word, Microsoft Excel, Microsoft PowerPoint

• Preparing shipments according to compliance of materials for customer purchase orders• Creating Certificates of Analysis, Specifications, MSDS, Sales Orders• Assuring that purity of vendor raw materials and final products are in compliance with specifications of purchase orders• QuickBooks/Scanning/Filing/Documentation/Avery Product Labels• Preparing final paperwork for shipment

Master'S Degree, Pharmaceutics

Bachelor'S Degree, Biochemistry