Syngene QA-Reviewer Post Vacancy – B Pharma Jobs
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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.
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