11/17/2023 updated
PV
100 % available
Free Lance Consultant, Assistant Manager- Quality Assurance
Ahmedabad, India
Worldwide
Master in PharmacyAuditingGap AnalysisLaboratory Information Management SystemsQuality ManagementSAP ApplicationsTrackwiseProject Delivery
- Quality Management System
- Qualification and Validation
- MES
- Supplier Audit
- GAP Analysis
- SAP
- Trackwise
- Microsoft Word
- Microsoft Excel
- Microsoft Powerpoint
- LIMS
- Project Execution
Languages
EnglishFluentHindiNative speaker
Project history
- Review the Change Control, Deviation documents
- Prepare Audit Compliance Report
- Prepare the Validation Master Plan & Site Master File.
- Providing Technical consultant on new project execution.
- Providing Technical consultant to get more productivity.
- Prepare Audit Compliance Report
- Prepare the Validation Master Plan & Site Master File.
- Providing Technical consultant on new project execution.
- Providing Technical consultant to get more productivity.
- Handled Qualification and Validation activities of Process/ Packaging equipment,
utilities, IT systems according to v model.
- Prepared/ Reviewed URS, FRS, DQ, IQ, OQ and PQ protocol.
- Executed FAT/SAT, IQ, OQ and PQ activity of manufacturing and packaging
equipments on site.
- Executed utility as HVAC, Water system, Compressed Air, Nitrogen system to
evaluate its design specification through IQ, OQ and PQ activity.
- Performed PLC validation as per GAMP5.
- Prepared traceability matrix of each equipment to meet the user requirement in
IQ, OQ and PQ activity.
- Finalized facility layout for the approval of local state authority.
- Effectively implemented quality management system for the operation of the
plant.
- Ensured the documentation for implementation and maintenance of equipment
in complaint with internal and external requirement.
- Performed improvement plans of GAP analysis through quality management
system, updated SOP's as per requirement.
- Consulted in Manufacturing Execution System manufacturing projects as a part
of project team to make sure all user and regulatory requirements were met.
- Ensured planned tasks and leads on potential new tasks with focus on deadlines.
- Handled authority inspection from Europe, USFDA, Brazil, and WHO GMP.
utilities, IT systems according to v model.
- Prepared/ Reviewed URS, FRS, DQ, IQ, OQ and PQ protocol.
- Executed FAT/SAT, IQ, OQ and PQ activity of manufacturing and packaging
equipments on site.
- Executed utility as HVAC, Water system, Compressed Air, Nitrogen system to
evaluate its design specification through IQ, OQ and PQ activity.
- Performed PLC validation as per GAMP5.
- Prepared traceability matrix of each equipment to meet the user requirement in
IQ, OQ and PQ activity.
- Finalized facility layout for the approval of local state authority.
- Effectively implemented quality management system for the operation of the
plant.
- Ensured the documentation for implementation and maintenance of equipment
in complaint with internal and external requirement.
- Performed improvement plans of GAP analysis through quality management
system, updated SOP's as per requirement.
- Consulted in Manufacturing Execution System manufacturing projects as a part
of project team to make sure all user and regulatory requirements were met.
- Ensured planned tasks and leads on potential new tasks with focus on deadlines.
- Handled authority inspection from Europe, USFDA, Brazil, and WHO GMP.