20 - 25 years
45 - 50 Lacs
Posted:1 week ago|
Platform:
Work from Office
Full Time
Lead & supervise all QC lab functions include chemical, instrumental, microbiological testing.
Ensure timely and accurate analysis of raw materials, intermediates, APIs, packaging materials.
Maintain and calibrate analytical instruments (HPLC, GC, FTIR, UV-Vis, etc.).
Ensure full compliance with cGMP, ICH guidelines, and all relevant regulatory requirements.
Prepare for and lead regulatory and customer audits (USFDA, MHRA, EDQM, WHO, etc.).
Manage CAPA, OOS, OOT, deviations, and change control processes.
Oversee preparation and review of all QC-related SOPs, protocols, reports, and test records.
Ensure proper documentation practices and data integrity in line with ALCOA+ principles.
Maintain LIMS or other digital lab systems.
Supervise and review analytical method validation and method transfer activities.
Support R&D and manufacturing with analytical troubleshooting and investigations.
Lead, mentor, and train QC staff to build technical capability and GMP awareness.
Set performance objectives, conduct appraisals, and support employee development.
Oversee stability study program for APIs per ICH guidelines.
Ensure appropriate environmental monitoring of QC labs.
Manage the QC lab budget, procurement of lab reagents, consumables, and capital equipment.
Optimize resource utilization and lab efficiency.
Pharmazell
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