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.
• 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.
• 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.
• 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.

• 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.