QC Analyst

Job Description:

Responsibilities

• Responsible for laboratory activities including sampling, testing, and release of raw materials, packaging materials, and finished products.
• Review and approve analytical results and Certificates of Analysis (CoA), ensuring timely material disposition in SAP.
• Manage quality systems including OOS/OOT, deviations, change controls, and Annual Product Quality Reviews (APQR).
• Ensure compliance with cGMP, GLP, and regulatory requirements across all QC operations and documentation (SOPs, STPs, DMS).
• Oversee laboratory operations including instrument qualification/validation, calibration, stability studies, and reagent/chemical management.
• Support audits, regulatory inspections, vendor management, and coordination with external laboratories.
• Develop continuous improvement initiatives while ensuring adherence to EHS standards.

Qualification & Expeirnece

• Degree in Pharmacy, Chemistry, or a related Life Sciences discipline.
• 1-3 years Strong experience in Quality Control within pharmaceutical or regulated manufacturing environments.
• In-depth knowledge of cGMP, GLP, and quality systems (OOS, deviations, change control, APQR).
• Hands-on experience with analytical techniques and laboratory instrumentation (e.g., HPLC, GC, UV, dissolution).