Sandra Mcsweeney Email & Phone Number

Tel-Aviv, Il

• Executed process and packing validation to support new product introduction and process and equipment changes. This involved the generation of validation protocols, collaboration with associated departments, interpretation and analysis of in-process control and Quality Control results. Final compilation of the validation report. • Managed the review and approval of Engineering Department validation documents such as design briefs, user requirement specifications (URS), installation operational qualification (IOQs), engineering reports and quality risk assessments.• Managed temperature mapping of manufacturing/packing areas, storage areas and stability cabinets. Involved scheduling of mapping, generation and execution of protocols, analysis of results and investigation of deviations where required.• Performed internal and external quality audits.• Prepared for and participated in regulatory audits, such as US FDA, IMB (Irish Medicines Board) and corporate quality inspections.• Reviewed and approved documents such as SOPs, annual product reviews (APR), Bills of Material (BOM) and multi-department reports using change control to ensure compliance with regulatory and GMP requirements.• Evaluated and approved Quality Control Out of Specification (OSS) reports using Trackwise quality management system software.• Evaluated and approved Corrective and Preventive Actions (CAPA) in a timely manner to maintain site compliance.

• Reviewed completed batch manufacturing and packing records for intermediate and finished product release, ensuring all documentation met cGMP and quality requirements.• Reviewed and approved Incident Reports (IR), Non-Conforming Material (NCM) Reports and Yield Variance Reports.• Monitored the quality systems through reporting of metrics and trends as well as the compilation of QA monthly and annual IR and NCM reports.• Managed incoming inspection of components for both Inhalations and Solid Dose manufacturing and packing including documentation control and release via SAP.

• Performed Spectrophotometric analysis of raw materials and color products.• Performed Color and gel analysis of hydrocolloid products.• Performed Microbial analysis of raw materials and finished products.• Managed Environmental monitoring of plant and equipment.• Generated and approved certificates of analysis.• Completed customer questionnaires.