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0.0 years
0 Lacs
india
Remote
Assist in the validation of Track and Trace and Inspection systems, including drafting and executing IQ, OQ, IOQ and PQ protocols. Support system verification activities to ensure compliance with 21 CFR Part 11 and other regulatory standards. Collaborate with cross-functional teams (Development, Engineering, IT, PMO, Production, Service) during implementation and testing phases. Review and maintain validation documentation, including test scripts, deviation reports, and traceability matrices. Monitor and report system performance, helping to identify non-conformities and supporting CAPA activities. Participate in audits and inspections, providing validation records and technical support as n...
Posted 6 days ago
5.0 - 9.0 years
0 Lacs
gujarat
On-site
As a Production Manager - Injectable Manufacturing based in Chhatral, Gandhinagar, your role will involve overseeing the daily operations of the manufacturing facility. You will be responsible for ensuring adherence to production schedules and quality standards. Your key responsibilities will include: - Supervising production staff to ensure smooth operations - Developing production plans to optimize efficiency - Coordinating with other departments for seamless workflow - Maintaining compliance with regulatory requirements - Implementing continuous improvement initiatives for enhanced productivity Qualifications required for this role include: - M.sc/ B.Pharm/ M.Pharm - 5+ years of experienc...
Posted 1 week ago
5.0 - 10.0 years
5 - 9 Lacs
visakhapatnam
Work from Office
We are looking for a meticulous Warehouse Asst Manager to optimize our API warehousing operations at Synnat Pharma. As the Warehouse Asst Manager, you will play a crucial role in managing the receipt, storage, and dispatch of raw materials, packing materials, and finished goods, ensuring compliance with GMP and GDP standards. This involves maintaining inventory accuracy, overseeing dispensing procedures, and handling regulatory audits. You will supervise warehouse staff, manage customs activities, and ensure materials are stored and transported under appropriate conditions. The role demands a proactive individual capable of independently managing warehouse operations, maintaining stock level...
Posted 1 month ago
2.0 - 7.0 years
0 Lacs
maharashtra
On-site
You should have 2-7 years of experience in an Injectable plant. Your main responsibilities will include making entries of Bonding slips, preparing monthly statements for LL party and sales reports, generating GST invoices in Pharma Cloud, preparing E-way bills, creating and reviewing standard operating procedures for the BSR department, implementing departmental SOPs, managing quality system documents like Change control proposals, Deviations & Incident reports, updating and maintaining online departmental documentation, uploading all Third-party invoices on the party portal, following export consignment dispatch procedures, ensuring proper handover of charge before leaving the factory, coor...
Posted 1 month ago
5.0 - 9.0 years
0 Lacs
maharashtra, tarapur
On-site
You will be responsible for supervising and guiding the IPQA team to conduct real-time monitoring during manufacturing and packing processes. Your role will involve ensuring compliance with BMR/BPR review and approvals at each stage, as well as overseeing line clearance before manufacturing and packaging activities. It will be essential to monitor critical process parameters, in-process checks, and control sampling activities including IPC, stability, validation, etc. You will be expected to ensure timely review and approval of executed batch records and logbooks, review and ensure compliance of standard operating procedures (SOPs), and maintain and control GMP documentation related to IPQA ...
Posted 2 months ago
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