Franchesca Zarzuela

• Created and collaborated in implementation and maintenance of customer complaint log and execution.
• Evaluating product complaints to determine if the complaint investigation process is applicable.
• Evaluate complaint for regulatory reportability and create and submit reports that comply with applicable regulations.
• Perform complaint investigations with multi-department SMEs in compliance with the complaint handling process.
• Perform deviations investigations with multi-department SMEs in compliance with the deviation management process.
• Assists process owners with the root cause analysis.
• Responsible for the submission of semi-annual electronic drug product reporting to FDA.
• Writing annual product quality reports and overseeing subsequent CAPA if requested.
• Responsible for reviewing and/ or approving investigations/ deviation, and Complaints.
• Monitors Quality Metrics and KPIs.
• Participates in regulatory audits, assist in maintenance of audits records and documenting follow up from audits.

• Provide overall leadership to Sterile production team.
• Preparation of commercial formulation products built to high standards of quality in accordance with Current Good Manufacturing Practice (cGMP).
• Carry out GMP Manufacturing activities according to clearly defined documentation and cleaning validation processes.
• Direct supervision of Technicians within GMP Manufacturing Facility to ensure that products are manufactured to required Quality and CGMP standards.
• Manage hands-on day to day running of production area to ensure all operations are undertaken and facilities maintained following company quality metrics and Standard Operation Procedures (SOP's).
• Review SOPs to ensure compliance with GDPs.
• Daily review of Batch documentation, equipment, and facility logbooks to ensure continual compliance.
• Assist in FDA inspection, audits, deviation Investigations and Corrective and Preventative Action (CAPA).
• Gown qualified to supervise production in cleanroom
• Certified to qualify technician to perform Manual Visual Inspection.
• Work closely with Quality Assurance department in batch record review and release.
• Supervise visual inspection, labeling, and packaging activities.
• Work in collaboration with Quality Assurance, Quality Control, Supply Chain, Product Development, and Maintenance departments.
• Ensure sterile production operations are properly controlled and regulatory compliance requirements are met by ensuring batch documentation is accurate, Standard Operating Procedures (SOP's) are accurate and personnel training is current.
• Assist with hiring and disciplining staff as required.
• Support company's safety program to maximize safety awareness and safe work environment.
• Supports continuous improvement by identifying potential issues to improve work processes and procedures relative to manufacturing.

Lead-Sterile Technician (07/2017 to 08/2019)

• Maintains CGMP environment.
• Follow aseptic gowning procedures.
• Gowning experience in ISO 5, 7, and 8.
• Prepares for production run by reviewing production schedules; identifying batch-specific requirements; weighing and measuring ingredients and adding to mixing equipment.
• Perform duties in aseptic gowning such as filling and compounding.
• Operates production equipment such as de-hydrogenation oven, autoclave, filter integrity, and labeler machine.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Performs various routine production tasks under guidelines of established Standard Operating Procedures (SOP's) and CGMP regulations.
• Responsible for all activities associated with manufacturing and filling operations, required to produce sterile drug products under aseptic conditions.
• Review batch record documentation, and logbooks to ensure good documentation practice.
• Oversee production technicians ensure all daily tasks are completed as required.
• Assist technical personnel on issues and problem.
• Cross-train in other areas such as Inspection, labeling, and packaging.
• Assists with training of new operators.

• Help health care providers and patients by greeting them in person and by phone; answering questions and requests.
• Maintains pharmacy inventory by checking pharmaceutical stock to determine inventory level; anticipating needed medications and supplies; placing and expediting orders; verifying receipt; removing outdated drugs.
• Organizes medications for pharmacist to dispense by reading medication orders and prescriptions; preparing labels; calculating quantities; assembling intravenous solutions and other pharmaceutical therapies.
• Maintains records by recording and filing physicians orders and prescriptions.