Shilpi Saha Email & Phone Number

Greater Seattle Area

• Manage planning, implementation, and sustain a site-wide quality management program.• Responsibilities includes managing day to day NC’s, Deviations, Complaints, CAPA, Document Control, Training, and Manufacturing Support. • Review Instrument Design History Records (DHR) on daily basis.• Chair Material Review Board on weekly basis and keep close update on material nonconformance and scrap data.• Lead implementation, controlling & testing of Incoming/In process quality control (IQC) process• Lead the investigation, update metrics and resolution of problems initiated through corrective action (CAPA) and customer complaints.• Responsible for departmental document change control, manufacturer change control and engineering change control activities.• Responsible for closing Return Merchandise Authorization activities for the Service Deport.• Maintain sidewise training metric and on-job training for the respective department.• Responsible for the first article inspection of purchased product. Design fixtures, determine method of inspection, and communicate engineering requirements to inspectors.• Generate quality data on a monthly basis for component and instrument-level quality. Identify trends, determine root cause, and provide corrective actions for technical instrument-related quality issues.• Run Supplier Quality Program, including supplier surveys, communicate and resolve technical issues and audit suppliers as required.• Responsible for design teams; drive departmental responsibilities for new and changed product design transfer phases• Work with Operations and R&D personnel to write and execute validation plans.• Responsible for running site wise continuous improvement projects. • Support production with on demand creation of work instruction, SOP or Bill of Material changes.• Assist in the calibration of equipment and tools and the maintenance of departmental facility cleanliness and integrity.

• Manage planning, implementation, and sustain a site-wide quality management program.• Responsibilities includes managing day to day NC’s, Deviations, Complaints, Document control, Training, and Manufacturing Support. • Chair to Material review board and run nonconformance metric for the site.• Lead implementation, controlling & testing of Incoming/In process quality control (IQC) process.• Responsible for inter-company production/technology transfer.• Work with Operations and R&D personnel to write and execute validation plans.• Support internal audits. • Managing efforts to ensure site alignment to ISO 9001 and ISO 13485 requirements.• Responsible for following site programs: • Supplier Quality Management • Complaint Management • Engineering Change Process Owner • CAPA Management • Production Sustaining Engineering Support • Operations / Manufacturing Support • Site training/ On job Training

Greater Seattle Area

• Lead implementation of a site Supplier Quality Management program. Work with leadership to align with divisional requirements.• Expand and formalize incoming quality inspection program (non-conformance disposition, return of material to suppliers, tracking supplier performance). Develop supplier quality plans using risk based assessments to determine inspection requirements and acceptance criteria.• Lead implementation of a local site internal audit program. Train other local auditors. Audit local quality processes such as Document Control, Training, CAPA, Deviation, etc. to ensure site procedures are followed.• Support site Quality Management System: Assist in the definition, implementation, and maintenance of quality processes and procedures supporting business and regulatory needs.• Support Corrective and Preventative Action Program (CAPA) for assigned product family – Identify problems, establish effective corrective actions, and work to resolve problems.• Document Control – Assist with management of document control processes.• Manage Regulatory Program (RoHS, WEEE, REACH) for assigned product family.• Manage investigation of customer complaints for assigned product family. Review and approve complaint records.• Work with Operations and R&D personnel to write and execute validation plans.

Greater Seattle Area

• Support Quality Management System and Corrective and Preventative Action Program (CAPA)• Document Control – Assist with management of document control processes. • Assist with administering and expanding site training program, including collection and organization of training records. • Coordinate completion of annual calibration activities. • Assist with regulatory technical file maintenance: RoHS Certificates, REACH, etc. • Participate in the investigation of customer complaints. Review and approve complaint records. • Test and inspect product at specified stages in the manufacturing process to ensure compliance with specifications. • Support incoming quality inspection program (non-conformance disposition, return of material to suppliers, tracking supplier performance). • Provide guidance to document authors to ensure accuracy, correctness and consistency. • Lead internal audits of quality processes such as Document Control, Training, CAPA, Deviation, etc. to ensure site procedures are followed. • Support internal and external audits. • Assist with generating monthly metrics for divisional and corporate leadership.

Nasik Area, India

• Performed In-Process Quality Assurance (IPQA) activities in various areas of operation ensuring current Good Manufacturing Practices (cGMP) compliance.• Monitored qualification and validation activities and performed necessary sampling and testing according to Standard Operating Procedure (SOP).• Knowledge of ISO 9001 and experience with the electronic manufacturing environment.Experience with Document Control, CAPA and Deviation• Certified line clearance activities and sampling of Finished product and Hold time as per product Batch Production and Control Record (BPCR) or protocol.• Online review of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR).• Participated in incident, deviation and out of specification (OOS) investigations.• Investigated market complaints, customer complaints and prepared reports.• Faced and passed audits by US-FDA, WHO (Geneva), MHRA, MCC, MCA, TGA, Sandoz and other countries.

Indore Area, India

• Prepared Asean Common Technical Dossier (ACTD), Common Technical Document (CTD) dossiers and short dossiers for various countries like South East Asia, Latin America and Africa.• Imported and registered biological product in India as well as prepared artwork and insert.

Master'S Degree, Pharmaceutical Sciences

Bachelor'S Degree, Pharmacy