Job Description
- Conduct product test according to SOP (Standard Operating Procedures).
- Perform processing & calibration of quantitative solution & prepare reports consequently.
- Provide accurate and concurrent laboratory results using data capture forms and laboratory Information management system.
- Perform material analysis process according to SOP & use the operational evidence for the laboratories testing implementation.
- Participate in trouble shooting and test problem resolution.
- Prepare daily reports throughout the operational stages & make sure that they are delivered to concerned department.
- Conduct routine equipment monitoring.
- Prepare Quality Control analytical documentation and reports.
- Understand and follow cleaning and disinfection procedures for all work areas.
- Initiate preparation & standardization of volumetric solution, test the solution and document every report and finding.
- Record analytical findings in the test respective logbook and confirm the calculation by updating it in SAP.
- Prepare approved labels for various stages of operation.
- Monitor temperatures in QC laboratory & make entry from time to time.
- Anticipate calibration and verification of QC instruments & QC balance regularly along with cleaning validation.
- Prepare COA for raw material, stability, packaging & finished goods.
- Notify supervisor of any deviation from set norms.
- Follow rejection procedure as per SOP.
- Perform sample testing, analysis & report preparation for water used for injection (Purified & Raw Water).
- Follow the documentation system requirements along with CGMP, GDP, GLP & EHS precautions.
- Set stability study samples & monitor stability chamber regularly.
- Formulate Raw Material Data Sheet (RMDS) by entering tested data.
- Perform standardization against reference standards as per valid approved test procedure.
- Report specifications like OOS/OOT if any.
- Ensure confidentiality of all documents and information related to work.
Perform any other duties related to the job according to the business needs
Bachelor Degree in Pharmacy, Science, Medicine or Chemistry
