Sanjay Vyas

Provides QA leadership to six separate manufacturing/packaging sites; manages manufacturing/packaging validation, batch record approval, manufacturing/packaging and shipping investigations, and change control. Oversees corrective and preventative action metrics as well as the development and revision of relevant internal and supplier procedures. Reviews and approves manufacturing/packaging validation protocols and final reports.

Managed three shifts in QA inspection and batch review and release for commercial distribution as well as release for granulation, blending, compression, coating, and encapsulation operations. Expedited releases through management of direct reports and follow-up actions. Oversaw the approval of all applicable site-controlled documents, including master batch record/packaging record review/approval, procedures, technical evaluation reports, process and cleaning validation protocols and reports.

Provided oversight of six direct and seven indirect reports working three shifts; managed line clearances and in-process inspection for 45 products. Developed protocols for additional testing and inspections to address deviations. Trained affected area personnel on protocol execution and testing. Performed production floor GMP audits and resolved daily quality and manufacturing issues. Investigated manufacturing discrepancies. Resolved manufacturing, packaging, and lab deviations.

Executed manufacturing/packaging line clearances; initiated QA hold notices for non-conformances; and performed in-process inspections, including weight variation and defect analysis testing. Reviewed and approved raw materials and finished product ‘Certificates of Analysis’ for batch release. Participated on project management teams for special projects, including the master packaging record creation. Performed test procedures for the qualification of the inventory control system (MFG-PRO).