Bala Srinivasan

As a Senior Quality/Compliance Managing consultant, support clients in Life Sciences and Medical device industries in areas of FDA regulations compliance, Audit, Process improvements and program management

a) FDA regulatory support for major IT Projects such as SAP upgrade project (SAP R/3, 3.1i -> ECC6) for Medical Diagnostics Division, including guidance on GxP (21 CFR Part 211/820/Part11), SoX compliance, and validation. b) Supported Diagnostic and Clinical Services Mobile Service 360 Asset Management project c) Investigated CAPA issues and documented findings in 'Trackwise' tool. e) Lean Six Sigma Process improvements in areas of compliance/validation, SOX

1. Quality , regulatory compliance and Validation tasks in all phases of product development life cycle from concept to production in Agile PLM, Page Vision, SAP ECC6 and Trackwise environment:. Set up best practice for Risk Analysis. 2. Development of Design Control involving design and Development planning, Design verification, Design review, Design transfer, Project management, Manufacturing Quality using Six Sigma. 3. Created validation deliverables, (DQ/IQ/OQ/PQ) per QSR 820

Program Management of multiple SAP and Other Projects at Leading USA Oil companies (Chevron/BP) and Automotive companies (General Motors/OnStar)

For the Global Research and Development Informatics Division (PGRDi), performed Program Quality Management & Validation functions on multiple complex global IT projects in Business process re-engineering of Knowledge/ Information Management (KM/IM), Six Sigma Bioinformatics projects such as Pharma Matrix, Insight Portal/ Documentum/ Verity Federated/Enterprise search & content management, in support of drug discovery, Innovation & Clinical trials. Managed and validated the complex Program deliverables.

Project & Quality Management of a large integrated GxP warehouse with SAP R/3 4.6 system. • Configuration, Validation and Integration of QM, RFID, MES, BMS, LIMS/GLP and Lean Six Sigma related processes with SAP R/3 Logistics system (WM/IM/MM/SD) • Creation & execution of DQ/IQ/OQ/PQs protocols for system validation

Worked on a healthcare financial analysis and reporting Data Warehouse project that was being built around an HIPAA compliant PeopleSoft Benefit environment (v8.x) interfaced with an OLAP/Business Intelligence tool. • Work involved VOC, Functional gap analysis, SIPOC Business process re-engineering, Value stream mapping, JAD sessions, QFD, Six Sigma CTQs, Project Scope Management tasks through documentation of Project Charter, and other Project deliverables

• Business analysis and Data migration for Legacy to PeopleSoft AM module conversion for a Health Insurance provider. • Configuration & customization of PeopleSoft HRMS, Purchasing, Finance modules for a Healthcare industry (DMC, Oakwood Hospitals) • Business analysis , & Project support for upgrades to Shop Floor Management Systems- Total Equipment Maintenance (TEM), and Electronic Document Management System (EDMS) that integrated with SAP R/3 system

For a Medical device company, established Quality systems best practices as per ISO 13485, QSIT/QSR 820 QMS for Class I & II medical devices; For a manufacturing industry, provided SAP R/3 (v2.2e, 3.0c) SD/MM/PP business process expertise in support of fit gap analysis, Business blue printing, process mapping, configuration, implementation, integration & system testing. Provided Executive interface between Director, and Project Managers.

• Due diligence audits of diverse bio-pharmaceutical, API manufacturing and biotechnology project sites to trouble shoot sterility problems, root cause failure analysis, Regulatory compliance and Process validations covering DQ/IQ/OQ/PQ • Validation of some of the Bio-fermentation systems with automation system (DCS/SCADA/PLC). Documented many process improvement issues and Corrective action Procedures (CAPA)/remediation action plans.

Consulting at • For Bio pharmaceutical, Dairy and Breweries clients, engaged in process optimization and Operational Qualification (OQ) in areas of Cleaning-in-place (CIP) and Steaming-in-place (SIP) by use of SOPURA specialty chemicals, through Design of Experiments. Conducted risk Analysis using Six Sigma Design FMEA and Process FMEA, FTA, reviewed validation documents;

ISO 9001 certified group, Designer, manufacturer and supplier of engineered Chemical process equipment, industrial Waste treatment plants and thermal systems. • Managed the supervision and administration of the Project department (comprising 10 engineers), that covered all activities from sale, application, project engineering, installation, Qualification, commissioning and validation of a very many capital equipment projects

• Administration and direct supervision of the project department for the Process industries group comprising 7 Engineers. Participated in Product engineering tasks to customize the products to meet client’s requirements. • Program Management & matrixed leadership of Complex global projects jointly with parent company in Germany including development of QMS and Standard Quality Control Plans, Quality assurance and validation Plans & Qualification/Commissioning.

Business Process Integration with SAP ERP 6.0 (TERP10)

Mass Transfer, Heat Transfer, Thermodynamics, Statistics and other Chemical Engineering subjects