Address1) Coordination of the Supplier Qualification and Re-Qualification process for the Raw Materials, Packing Materials and Pharmaceutical Aids with concerned departments.
2) Responsible for preparation and review of Standard Operating Procedures (SOP’s), Corporate Quality Policies and Common Procedures in coordination with respective SMEs and the Eugia formulation sites.
3) Ensure updated questionnaires are available in DMS, current specifications are available with vendors.
4) Initiation and review of DMS, Change control, Process non-conformances and CAPA action items implementation.
5) Coordinating with the Purchase team for further requirement of sample(s) and/ or documents like certifications, compliance/investigation reports (if any).\
6) Reviewing of the Supplier Qualification Questionnaires/supporting documents and updating the Qualification status of respective material of supplier in Enterprise Resource Planning (ERP).
7) Scheduling of Onsite Audits. Uploading of Qualification documents, Onsite Audit Reports and Response to audit observations into DMS.
8) Preparation and review of Quality Agreements
9) Initiate change controls for change in existing supplier or alternate/additional suppliers
10) Review and approval of Business associate, approved vendor details in LIMS.
11) Review of Non-conformances/Out of specifications and updating the History Card of Suppliers
12) Responsible for issuance and retrieval of all documents in custody of CQA.
13) Initiation and modification of Job Responsibilities in Nichelon 5CMS software.
14) Initiate training course sessions and record attendance for Corporate Quality Assurance personnel in Nichelon 5CMS software.
15) On Site/Virtual Supplier Audits in Eugia - CQA for Raw Materials, Packing Materials, Pharmaceutical Aids suppliers, Contract Lab and contract manufacturer
16) Handling of QMS activities and training activities through EPIQ software.
