Ana Panyko

conducts internal and external audits, customer audit support, vendor management

• Conduct internal and external audits, categorize observations, and prepare reports • Write, review, and approve investigations, OOS, and planned deviations • Proposal of corrective/preventive actions, CAPA initiation, follow-through. • Manage CAPA and planned deviation action items and ensuring timely completion • Review and approve extension requests for CAPAs, investigations, and planned deviation action items • Coordinate timely distribution and training of SOPs and other documents for Pharmaceutical Services Division, and maintain the training database • Review and approve documents through change control- backup for QA Document Control Specialist

• Coordinated adherence to and execution of Customer Quality Requirements • Conducted pre-inspection audits for manufacturing areas in preparation for customer or FDA audits, communicate deficiencies, and coordinate corrective actions • Conducted internal audits of the QC/Analytical laboratory • Ensured compliance to cGMPs and internal SOPs through the Pharmaceutical Services Division through routine and special inspections • Released raw material and finished product batches • Investigated of deviations and failures and write reports • Proposal and implementation of corrective/preventive actions • Training of personnel • Prepared and presented topics for annual cGMP training • Authored, reviewed, and approved Protocols, Reports, Master Batch Records, and SOPs • Managed QA activities for cleaning validation and stability studies • Coordinated annual calibration and performed qualification of temperature and humidity loggers for all refrigerators, freezers, and stability chambers

• cGMP enforcement and training • Analysis (TOC) and maintenance of USP purified water • Testing for Batch Release • Batch record audit and revision • Customer liaison • Equipment Qualification protocol design and execution for analytical instrumentation • Engineering documents review and revision • Scale/Balance calibration, repair, and replacement coordination. Promoted to technologist in 2002.

• Analytical chemistry; QC and R&D technical support • Design, validation, documentation, and approval for testing methods to promote standardization and optimization of analytical practices. • Training of bakery and headquarters Quality and R&D personnel. • Instrumentation includes: Near-Infrared Analyzers (NIR), Atomic Absorption Spectrometers, UV-Vis Spectrophotometers, Laser-diffraction Particle Size Analyzers, and Pulsed NMR. • Formulations of products and preparation of bench top and pilot plant samples • Presentations of summary of work to senior management