Enaltec was established in 2006 by a group of young and experienced professionals with the specific objective to develop and produce complex, small volume, technology driven products at competitive prices, thus providing the critical India advantage to generic formulators across the world.
Job Title : DGM/Sr Manager
Department : Quality Control
Role Definition : As Head of Quality control manage QC, Micro & AMV
• Daily allocation of work to review reports and pending work if any.
• Planning of Raw Material, In-process samples aid finished product samples analysis aid ensure the completeness of analysis for Commercial and Exhibit Batches
• Responsible of Analysis of Process validation samples and its Documentation.
• Review of Stability Protocols and Reports for DMF submission.
• Review and compile Stability summary ad trends charts for Regulatory submission.
• Review of Analytical Method Validation Protocol and Reports.
• Review audit trials of all instruments
Education Qualifications : M.Sc-Chemistry / Pharmacy with experience in API USFDA approved plant, regulator/ plait
Relevant Experience : 10+yeas in QC in API (USFDA approved Plat). Faced USFDA Audits directly.
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