Quality Control Analyst

Description:Perform day to day activities for the chemical laboratory which shall include testing of in- process, RM, PM and FP samples, Swab sample and Tech Transfer (as applicable).Ensuring compliance to systems and procedures throughout product lifecycle.Communicate with Supervisor and/or report any preparations or data that may result in an Incidence & OOS.Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits.Execute technology transfer of analytical methods for new products. Execute cleaning validation of new products.Assist in the monitoring of changes in the monographs Pharmacopoeia requirements, Regulatory agencies recommendations and implement the same in QC Lab.Apply CAPA for Lab failures in OOS.Complete and maintain certified investigator training requirements to ensure SIT representation for identified area(s).Performing the investigation of quality events assigned using root cause analysis tools defined by company procedures, maintain timelines for closure of investigations assigned and to identify and initiate CAPA's.Participate in continuous improvement initiatives for investigations and associated investigation certification process.Work with CIT team as needed for Major and Critical Investigations to align with corporate guidelines.Requirements:B.Sc. in Chemistry1-3+ years in the field of Pharmaceutical (manufacturing facility).Background in the functional areas of Quality Control in Stability, Finished Goods and some Raw Materials with a some experience in R&D.Extensive knowledge in general laboratory equipment including but not limited to: HPLC, UV-Vis and FTIR.Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market compliant management system.Skills in coordination of calibration and preventative maintenance services, including but not limited to: setting up vendor contracts, processing quotes, generating purchasing orders and handling vendor invoices.Technical writing skills to generate SOPs and serve as the Subject Matter Expert.Completed training on Six Sigma, certified Green belt professional.

Created: 2025-02-02