Keyur Patel Email & Phone Number

Vadodara, Gujarat, India

Vadodara, Gujarat, India

• Led site quality functions including quality control compliance • In collaboration with a team of 7 members, driving QMS, batch release, change controls, investigations, audit & compliance & Supplier Qualification.• Assist in the generation of the Supplier Audit schedule, Performed onsite supplier audit. Preparation and Review of Supplier audit report & Supplier Quality Agreements• Review and approval of SOPs, Specifications, Batch Records & analytical documents • Administering change controls through Caliber QAMS software.• Investigations and route cause analysis of OOS, OOT, Deviations & Laboratory Incidents• Review and Approval of CAPA, CAPA Effectiveness and Quality Risk Management• Preparing quality metrics status reporting to management. • Actively participating in customer audits as well as in regulatory inspections and support all activities to ensure inspection readiness • As a subject matter expert, safeguard compliance with cGMP, Global Guidance/Quality System, site policies/procedures, regulatory requirements and industry standards• Manage Reserve samples including annual visual inspection of reserve samples• Monitoring and implementation of Pharmacopoeia updates• Defining and executing processes for continuous improvement efforts

Ankleshwar

• Investigation and root cause analysis of laboratory incidents / deviations, OOS, OOT, Market Complaints, extraneous peak and Out Of Calibration• Monitored, reviewed & approved CAPA effectiveness checks• Operational excellence to improve efficiency and to promote continuous improvement• Preparation and review of trend of OOS, OOT, Deviation & CAPA. • Conducted gap analysis in quality system to resolve issues• Managed and investigated non-conformances and took corrective/preventative actions in compliance with quality procedures, policies and regulations

Vadodara Area, India

• Driven Quality Control compliance along with cross-functional QMS teams• Review & Approval of change control, Specification, test methods, SOPs, analytical documents, AMV, AMT, AME Protocol/Report, Instrument/Equipment Qualification, software qualification, Stability/ Hold Time study protocol & Report• Data Integrity Risk Management for various software in quality control laboratory• Ensure inspection readiness. cGMP compliance area walk-throughs of Manufacturing Operations, support and participate in site self-inspections and regulatory audits• Monitored compliance for qualification of suppliers, material, instruments and validation

Vadodara, Gujarat, India

• Management of In-Process QA (IPQA) activities and sampling• Planned, managed and executed Annual Product Quality Reviews (APQR)• Led batch disposition process - reviewed, identified discrepancies, verified limits and specifications• Managed the Documentation System. Archive, storage, retrieval and destruction processes

Postgraduate Degree, Regulatory Affairs, 90%

Master Of Science - Ms, Pharmaceutical Manufacturing

Bachelor Of Pharmacy - Bpharm, Pharmacy