Chemist C

Job Description

Job Summary:

• Responsible for ensuring compliance with Good Laboratory Practices (GLP), cGMP requirements, and internal quality standards within the Quality Control laboratory.
• Oversees laboratory compliance activities, including review of analytical documentation, data integrity verification, laboratory audits, investigations (OOS/OOT/Deviations), CAPA management, and regulatory inspection readiness.
• Supports the implementation and continuous improvement of quality systems, analysis of analytical samples (RM/PM/SFG/FG/Stability).

Duties & Responsibilities: 

• Ensure compliance with Good Laboratory Practices (GLP), cGMP, Data Integrity, and applicable regulatory requirements.
• Review and maintain laboratory documentation, including analytical worksheets, logbooks, instrument usage records and Audit trail of different software.
• Perform periodic laboratory audits and identify gaps related to GLP compliance.
• Support/perform investigations related to OOS, OOT, Deviations and CAPA.
• Review analytical data for completeness, accuracy, and compliance with ALCOA+ principles.
• Manage laboratory documentation systems and ensure timely archival and retrieval of records.
• Participate in preparation and support of regulatory inspections, customer audits, and internal audits.
• Review laboratory equipment qualification, calibration, and maintenance records for compliance.
• Monitor laboratory housekeeping and maintain compliance status of laboratory areas.
• Track and trend laboratory compliance metrics and prepare periodic quality reports.
• Collaborate with QA, QC, Manufacturing, and Regulatory Affairs to ensure regulatory compliance.
• Ensure timely closure of investigations, CAPAs, and change controls related to laboratory activities.
• Review and approve laboratory documents, protocols, reports, and compliance assessments as assigned.
• Analysis of RM/PM/SFG/FG/stability samples.
• Perform the calibration of Laboratory instrument.
• Management of Primary and Secondary standard in Laboratory.

Required Qualification:

• Minimum BS with Scientific field.
• BS with Chemistry is one of the subjects would be preferable.
• Minimum 4-6 years’ experience in pharmaceuticals and must have 3–5-year experience in Analytical testing.
• 3 years QC experience in Generic Pharmaceutical industries would be preferable Knowledge in Good Documentation.
• practices. Knowledge in USP/ICH/FDA.