Vantaggi
Participation in MES implementation as per ISA S95, a) MES to DCS Integration, b) Management of master batch records, c) Execution of electronic batch record, d) Warehouse management, weighing and dispensing, e) Equipment log, f) Deviation handling g) Qualification as per GAMP V Model, (Design Qualification, Development Implementation, Factory and Site Acceptance Test, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)) New technology Adoption a) Implementation of PAT tools in process (FTIR) and in cleaning (UV), b) Dia-filtration (hallow fiber membrane system)system for salt separations, c) Closed charging system and Clean in process Successful completion of Six sigma projects by using DMAIC approach a) Define (VOC to CTQ, Project charter, SIPOC, Stake holder Analysis) b) Measure (DPMO calculation etc) c) Analysis ( Cause effect analysis, why-why analysis for Root cause, Prioritization, validation of prioritized root causes) d) Improve (Solution generation ,Prioritization, risk assessment, implementation) e) Control.
Svantaggi
Observation of demo trails and report generation, Preparation of scale up documents for validation a) Preparation of batch record. b) Preparation of cleaning records and sampling guidelines, c) Writing and executing protocols and test cases for validations. d) Master plans, e) Validation protocols, f) Requalification’s, g) Technical reports, h) Specific validation procedures i) Safety and hazard evaluation, preparation of Process Flow Diagrams, Piping and Instrumentation drawings and assessment of equipment needs, documentation of campaign configurations by implementing small capital projects, when necessary, to modify or purchase equipment needed, providing scientific/technical expertise for process improvements and innovative approaches to production and validation activities Coordinating testing and documentation of projects. (Modification, simulation trails, adequacy checks... etc...) Identifying exceptions, performing effective root cause analyses, and implementing effective corrective actions , Preparation of validation final report. Work with other departments, including Manufacturing Technology, Engineering , QA and Complete all required documentation for proper traceability complying with regulatory requirements