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0.0 - 1.0 years
2 - 3 Lacs
ahmedabad
Work from Office
Role & responsibilities Operate aerosol filling and packaging machinery including spray dryers, capsule filling, blister packing, and secondary packaging equipment Perform weighing, blending, dispensing, mixing, granulating, drying, and coating processes as per batch production records Conduct machine changeovers and setup for different product batches. Monitor equipment parameters and ensure operations are within defined specifications. Ensure compliance with SOPs, cGMP, and regulatory requirements. Participate in audits and inspections as required. Perform routine equipment cleaning and maintenance. Assist in troubleshooting and resolving equipment issues.
Posted 3 weeks ago
0.0 - 1.0 years
2 - 3 Lacs
ahmedabad
Work from Office
Role & responsibilities Operate aerosol filling and packaging machinery including spray dryers, capsule filling, blister packing, and secondary packaging equipment Perform weighing, blending, dispensing, mixing, granulating, drying, and coating processes as per batch production records Conduct machine changeovers and setup for different product batches. Monitor equipment parameters and ensure operations are within defined specifications. Ensure compliance with SOPs, cGMP, and regulatory requirements. Participate in audits and inspections as required. Perform routine equipment cleaning and maintenance. Assist in troubleshooting and resolving equipment issues.
Posted 3 weeks ago
14.0 - 20.0 years
40 - 60 Lacs
bengaluru
Hybrid
Role & responsibilities Provide strategic leadership and oversight for regulatory submissions (original applications, supplements, and responses) for complex generic products, specifically semi-solids, transdermals, and nasal sprays. Drive early FDA engagement to align on development strategy, reduce regulatory risk, and support first-cycle approvals. Lead regulatory assessments and decision-making for significant changes, including site transfers, formulation modifications, and alternate API sourcing. Ensure submission documents are accurate, complete, and compliant with FDA regulations, promoting a Right-First-Time approach to maximize first-cycle approvals. Represent Regulatory Affairs in...
Posted 1 month ago
2.0 - 7.0 years
3 - 8 Lacs
Naidupet
Work from Office
(We are looking fo the Immediate joining candidates or willing to leave early for their current company) Role & responsibilities HPLC Analysis of Solid Orals/Nasal hands on experience on QC activities, RM, Packing, In Process and Finished Products Compliance with GMP/GLP Practices Preferred candidate profile 2-7 years of experience Prior experience of working in Regulated plants (USFDA/MHRA Approved) Perks and benefits Working in a state-of-the-art fully automated world class manufacturing. Opportunity to work on diverse dosage forms in a multi-product facility. Attractive attendance bonus & Special Allowances Unmatched opportunities to learn and grow Thanks & Regards Dhivakar D BVR People C...
Posted 3 months ago
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