Amol Basaiye
Pharma MFG-Packaging operation l Green field Project l IIP l Ex-Lupin l Ex- Wockhardt l Ex- Torrent l Ex- Macleods l
- Role
- Team Lead at Ferring Pharmaceuticals
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Amol Basaiye
17 Years of Experience in MNC Pharmaceutical regulatory USFDA-EU approved…
Experience
Team Lead
Jan 2024 — Present · Hyderabad, IN
Green field Project (From initial Installation and commissioning stage) Entire packing & Development operation, New Packing material development, Changepart development, Trials of machines and Packing material, Installation and Qualification -URS, DQ, FAT, MC, SAT, IQ, OQ, PQ, New SOP, Computer system validation, New Batch records, Packing development related activities, Review of Packing material specifications, Artwork review, Manufacturing activities, planning, Serialisation, Antares Vision Track and Trace system, Risk assessment, Vendor assessment for material, New Vendor, Change management, Quality management, QMS Documentation like Change control, Deviation, Investigation etc, Risk assessment, Packaging process Qualification, Protocols and reports for Exhibit and commercial packing, commissioning activities, eBRs, Automation, Audit, cGMP compliance, Technology Transfer activities related to packing, GMP Document review and compliance, Veeva, EDMS, DMS, LMS, SAP etc.Successfully completed international FAT for Automated Marchesini Robotics and other Packing lines and Track and trace system in Europe.Preparation of New SOPs and Process, Preparation of process Risk assessment, Packing validation, Coordination with different CFT and foreign vendors for smooth Production activity.Achievement: Best Team lead Award and GMN Global award at Ferring for exceptional performance and achievements of milestone.Completed Packing development Technology Transfer Training workshop and execution at Switzerland (Ferring international center Switzerland)
Education
North Maharashtra University
Bachelor of Pharmacy - BPharm, Pharmacy
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