Posted:1 month ago|
Platform:
Work from Office
Full Time
1) Responsible for PLC validation and performing CSV of plant equipment work as per cGMP & GDP.
2) Responsible for the operation of all QMS documents of plant process equipment.
3) Maintaining CSV related schedule.
4) Responsible for the preparation of all QMS documents, perform PLC validation activity, CSV activities of the systems under track and trace project and manufacturing equipments as well.
5) Support in periodic review of PLC validation of plant process equipment, Serialization/Track & Trace and Computerized System validation to QA qualification team.
6) To enforce safety rules and regulation in plant and expected to work in plant premises as per the respective sop.
7) Responsible for automation of Serialization process through the Deployment of Serialization/Track and Trace solution.
8) Implement & Manage Serialization/Track and Trace solution for all Manufacturing plants/sites of Alembic Pharma.
9) Integration of Alembic L4 (rfxcel) solution with all Brand Owners/MAH & also with Alembic CMOs.
10) Review the activity of EPCIS data sharing with all eligible serialization partners.
11) Work with equipment & software vendors, material vendors, SAP related activity & local QA to develop optimal specifications for Serialization/Track and Trace solution.
12) Troubleshooting of Serialization/Track and Trace computerized Systems with the help of internal or external support.
13) User Management and roles assignment for computerized systems related to Serialization/Track and Trace solution.
14) Backup management for Serialization/Track and Trace solution software using SOP.
15) Responsible for IT Manufacturing Compliance.
16) To Follow the GAMP and Serialization guidelines.
Alembic Pharmaceuticals
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