QC Chemist for API Industry
1 day ago
Job Description:
Key Responsibilities:
Analytical Operations:
Perform routine and non-routine analysis using HPLC, GC, UV and other instruments.
Conduct and support analytical method validations as per regulatory requirements.
Review and approve analytical data, test reports, and batch release documents.
Ensure proper calibration and qualification of laboratory instruments.
Manage Quality Management System (QMS) activities including:
OOS, Deviations, CAPA, Change Controls, and Audit Management.Prepare and maintain GMP-compliant documentation.
Participate in regulatory and customer audits.
Oversee inventory management of chemicals, reagents, and lab consumables.
Ensure compliance with GMP, GLP, and company SOPs.
Train and supervise junior QC staff (for managerial roles).
API QC experience is mandatory.
Hands-on expertise in HPLC, GC, UV, and analytical method development/validation.
Familiarity with ICH guidelines, GMP, and regulatory expectations.
Strong documentation and communication skills.
Experience in QMS and audits is a must for senior roles.
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