Sweta Singh

· Currently assisting in the qualification of a new line with responsibilities including FAT/SAT reviews, requirement verifications, functional risk and criticality assessments for the new clinical Flex Filling Line equipment (Isolator, Terminal Sterilizer, Filler and Lyophilizer) using integrated C&Q and design by Quality approach.

· Extensive knowledge and hands-on experience on equipment, processes and systems within an aseptic manufacturing facility used for parenteral production, such as steam sterilizers (autoclaves), dry heat sterilizations (depyro oven, tunnels), chemical decontamination (CDMAL, Isolator), tanks, lyophilizers, vial washers, parts washers, temperature controlled units, sterile filtration system, airflow visualizations and software (Microsoft excel spreadsheets).

· Implementation of Belimed Autoclaves with load development, bracketing and optimization of the validation approach using risk to reduce further requalification activities per EN285 regulatory requirements.

· Extensive collaboration with cross functional teams across the organization to develop validation protocols, deviations and reports for various processes and equipment on-site.

· Development of a risk-based family approach for tanks to reduce the qualification/ requalification activities to be performed annually resulting in shortened down time from production and a reduced workload for the Validation department.

· Developed a risk assessment report to analyze aseptic filling interventions in the ISO class 5 and 6 areas resulting in efficient resource utilization for airflow visualization studies.

· Successfully trained new personnel on critical manufacturing equipment, and their respective validation/ revalidation projects in both San Dimas and La Verne facilities. Experienced in hands on training for probing/ sampling techniques and data analysis.

· Maintenance & continuous improvement of equipment/processes by reviewing change managements, validation reports, Maintenance workorders, Preventive maintenance tasks and schedule, to align with changing requirements and specifications.

· Provided Validation support on equipment and processes during FMEA, risk analysis.

· Exhibited leadership during qualification/revalidation activities by managing field activities with a cross functioning team.

· Independently validated equipment and processes from inception to production handover with operator training.

· Acted as a liaison between Validation Management and Quality Approvers to meet deliverable project timelines, manage personnel support, assess qualification gaps, and update Standard Operating Procedures.

· Possess extensive knowledge in principles of equipment functionality and cleaning procedures.

· Performed requalification of Autoclaves, Lyophilizer and Tank SIPs, depyro Ovens, IMA Tunnels, Glassware Washers and Analytical Equipment.

· Prepared, executed, and performed data review for IQ, CQ, OQ and PQ protocols for temperature-controlled units such as walk-in refrigerators, freezers, stability chambers and warehouses.

· Proficient in temperature mapping software, including Kaye Validator, Ellab, Datatrace, and historical data analysis programs including: MAXIMO, GTRACK, and SCADA.

· Assisted air flow visualization studies in ISO 5 and 6 environments, verifying flow patterns for HEPA filters, doors, windows, vents, and product path.

· Generated revisions to Standard Operating Procedures and forms for process improvement.

· Coordinated amongst departments to formulate resolution to deviations and outstanding issues.

· Generated reports pertaining to Annual Quality Review of products manufactured and packaged onsite.

● Managed validation activities with multi-departments to ensure requalification projects are completed on-time.

● Developed and executed qualification/life cycle documents such as IQ/OQ/PQ and Requalification protocols for the qualification of GMP manufacturing equipment and processes in support of the manufacturing of Aseptic Injectable Pharmaceuticals

● Directed Autoclave Performance/Requalifications for moist heat bioburden reduction, and Equipment Steam-In-Place Sterilization qualifications

● Executed Airflow Visualization Studies for aseptic manufacturing and ISO controlled environments

● Partnered in the initial qualification of a novel flex filling line including HVAC systems, Nitrogen/CDA/WFI distribution systems, compounding equipment, TCU’s, Isolator, Airflow Studies, and initial Media Fill studies

● Oversaw aseptic intervention and media fill program, drafted media fill requalfication protocols and reports.

● Performed Periodic Reviews of equipment which consisted of identifying trends, investigating root causes, and developing CAPA plans in response

● Other projects: Lyophilizers, Depyrogenation Tunnels, Isolators, Controlled Temperature Chamber Mapping, Internal Vial Washers, Sterile/Process Tanks, VHP Decontamination Systems