Syngene QA Reviewer Job Vacancy - Pharma Candidates Apply

Syngene QA Reviewer Job Vacancy – Pharma Candidates Apply

Syngene QA-Reviewer Post. MSc QA-Reviewer Jobs @ Syngene. Career @ Syngene. MSc jobs. Interested and Eligible candidates may apply online. job opening at Syngene 2020. RA job opening 2020 at Syngene.Check out all the details on our website

Job Title: QA-Reviewer/Document Coordinator(Analytical Lab) (8161)

Work Experience 1-3 years


M.Sc./B.Pharm/M. Pharm

Technical Skills/Experience Required

  • Should have a minimum of 1-year experience in Chemical/Chromatographic testing in laboratory-QC.
  • Should be aware about the cGMP, Data Integrity, Good Documentation Practices, Good Laboratory Practices,
  • Should be aware about the Calibrations, Volumetric Solution preparations.
  • Should be aware about the different QC functions working like Method Validation,
  • Should have awareness of the different workstreams functioning of QC such as Finished Product, Raw material, Method Validation, Stability, etc.
  • Should be willing to come in 1st or 2nd shift as per the work requirement.

Following are the Job Description/Responsibilities but not limited to-:

  • Involve in the day to day activities of Analytical QA pertaining to Analytical Laboratory functions.
  • Issuance of the Numbers, Forms such as Protocol, OOS, OOT, Deviations, Change Controls, etc. and their evaluation.
  • Preparation, Review and Approval of the master documents such as SOP/IOP/EOP/GP/ODS.
  • Review and Approval of the executed ODS including the Method Validation, verification, Calibration and routine workstreams.
  • Issuance and withdrawal of Logbook, SOP, IOP, EOP, GP etc. and annexures wherever applicable and maintenance of issuance/ withdrawal records.
  • Monitoring the usage of current approved procedures in all relevant departments.
  • To ensure compliance with cGMP as laid down in the procedures.
  • Verification, authorized for Approval and reconciliation of analytical reports received from Quality Control.
  • Maintenance, issuance and control of master documents.
  • Ensuring online documentation and timely entry of operations performed in laboratory during testing.
  • Monitoring the revision of specifications and test methods to ensure compliance with statutory and company standards.
  • Monitoring and ensuring software controls used in the laboratory.
  • Preparation of trends/data bank of different types of non-conformities.
  • Monitoring of samples receipt and inception, incubation, labelling, pull out of samples as per the schedule and pull out window.
  • Monitoring of stability study conducted in accordance with the requirement specified in the respective SOP.
  • Ensuring training and/or re-training on current procedures and general topics to relevant personnel in a timely manner.
  • Any other assignment allocated by the reporting manager and/or above.

Apply Online

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