QC Officer / Associates || API Industry

This role is for a QC Officer / Trainee and Quality Control Associate for a leading Pharma API company in Mysore. The ideal candidate will have a background in M.Sc. Chemistry and experience in the Pharma API Quality Control domain. This role involves handling analytical equipment, ensuring compliance with GLP and 21 CFR standards, and performing various quality control analyses.

Key Responsibilities

• Analytical Equipment Handling: Handle and troubleshoot analytical equipment such as HPLC, GC-HS, FT-IR, UV, Potentiometry, Polarimeter, ICP, and KF.
• Methodology & Validation: Perform Analytical Method Development and Method Validations.
• Quality Assurance: Conduct the analysis of Inprocess, Stability, and FG Samples as per specifications.
• Equipment Maintenance: Operate, maintain, and calibrate HPLC and GC according to the schedule.
• Documentation & Reporting: Review results, release analytical test reports or Certificates of Analysis, and maintain minimum consumables in the lab.
• Compliance: Handle 21 CFR compliance and assist in the investigation of OOT/OOS (Out of Trend/Out of Specification) results.
• Sampling: Perform sampling of Raw Material, Inprocess, and Finished Product samples.
• Planning: Plan and coordinate to ensure the timely delivery of results.
• Software Knowledge: Basic knowledge of LIMS/SAP is required.

Positions & Experience

• QC Officer / Trainee: Requires 2 to 3 years of experience in a Pharma company.
• Quality Control Associates - API: Requires 5 to 9 years of experience in the Pharma API Industry.