Executive / Sr. Executive - QC / QA

For Quality Control (QC):

• Perform testing and analysis of raw materials, packaging materials, in-process materials, finished products, and stability samples.
• Ensure laboratory activities are performed in accordance with approved specifications, STPs, SOPs, and GMP requirements.
• Review analytical results, laboratory records, worksheets, and related documentation.
• Handle laboratory investigations, OOS/OOT results, and support root-cause analysis.
• Maintain proper documentation and ensure data integrity in QC activities.
• Ensure proper calibration, maintenance, and qualification of laboratory instruments.
• Coordinate with Production, QA, R&D, and other relevant departments when required.

For Quality Assurance (QA):

• Ensure compliance with GMP, GLP, GDP, and applicable regulatory requirements.
• Review batch manufacturing and packaging records and support batch release activities.
• Manage and review deviations, CAPA, change controls, OOS/OOT investigations, and related quality documentation.
• Prepare, review, and control SOPs and other quality documents.
• Support validation and qualification activities, including process validation, cleaning validation, equipment qualification, and related activities.
• Participate in internal audits, self-inspections, vendor qualification, and regulatory inspections.
• Monitor compliance with approved procedures and quality management system requirements.
• Coordinate with Production, QC, R&D, Engineering, and other departments to ensure effective implementation of the Quality Management System.