Quality Control Reviewer & Analyst

Role & responsibilities

Key Responsibilities QC (Injectable Plant)

• Perform testing of raw materials, in-process, finished products and stability samples.
• Handle HPLC, GC, UV, FTIR, KF and other QC instruments.
• Review analytical data, worksheets, chromatograms and calculations.
• Ensure compliance with cGMP, GLP, SOPs and ALCOA+ principles.
• Handle and support OOS, OOT, deviation and CAPA investigations.
• Maintain QC laboratory documentation and instrument records.
• Ensure timely completion of testing and reporting.
• Support internal, customer and regulatory audits.
• Follow laboratory safety, housekeeping and data integrity requirements.
• Perform testing of raw materials, in-process, finished products and stability samples.
• Handle HPLC, GC, UV, FTIR, KF and other QC instruments.
• Review analytical data, worksheets, chromatograms and calculations.
• Ensure compliance with cGMP, GLP, SOPs and ALCOA+ principles.
• Handle and support OOS, OOT, deviation and CAPA investigations.
• Maintain QC laboratory documentation and instrument records.
• Ensure timely completion of testing and reporting.
• Support internal, customer and regulatory audits.
• Follow laboratory safety, housekeeping and data integrity requirements.

Preferred candidate profile

Candidates currently working in pharmaceutical injectable/sterile manufacturing facilities with hands-on experience in analytical testing and analytical data review are preferred. Exposure to regulatory audits and USFDA-compliant quality systems will be an advantage.

Experience

• 3-7 years of relevant experience in Quality Control.
• Candidates with experience in injectable / sterile pharmaceutical manufacturing plants will be preferred.
• Experience in regulated facilities such as USFDA-approved plants will be an added advantage.