Syngene QA-Reviewer Post Vacancy - B Pharma Jobs

Syngene QA-Reviewer Post Vacancy – B Pharma Jobs

Syngene Pharma Scientist Post. Syngene Pharmacology Job. Syngene Job Opening. Pharma Jobs. Syngene Hiring Pharma candidates. candidates are required at Syngene. Interested and Eligible candidates may apply for the post via online mode. Check out all the details on Rasayanika.com.

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

Experience 1-3 years

Qualification M.Sc./B.Pharm/As per Company Policy

Department Quality Assurance(Analytical)

Reporting to Manager

Following are the 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.
  • Review and authorized for Approval of Qualification Protocols and Reports (URS/IQ/OQ/PQ) before and after the completion of activities related to
  • Instrument/Equipment Qualification External/Internal as applicable.
  • Issuance, evaluation and authorized for acceptance of CCF and closure of the same.
    Monitoring impact analysis and assessment for changes and authorized for Approval of the same wherever applicable.
  • Involve in the investigation of Incidences, Deviations, OOS, OOT, OOC, OOL etc.
  • Supporting responsible Baxter team member in batch disposition decision for batch under investigation for OOS, OOT test results based on laboratory investigation.
  • Ensuring on-line documentation and timely entry of operations performed in laboratory during testing.
  • Monitoring 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, labeling, pull out of samples as per schedule and pull out window.
  • Monitoring of stability study conducted in accordance with the requirement specified in the respective SOP.
  • Monitor the investigation in case of excursion/breakdown of Stability chambers/incubators. Verification of data for temperature and humidity generated from stability chambers/incubators periodically for compliance.
  • Review of Protocols and Reports for analytical activities.
  • Monitoring and authorized for Approval of activities pertaining to the shipment of samples for analysis at different locations.
  • Issuance and authorized for Approval of annexures related to the calibration of instruments and Equipment whenever and wherever applicable.
  • 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.
See Also
IISERB Technical Assistant Job Vacancy - Application Details

Apply Online

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