Work as Reviewer / Document Coordinator at Syngene International
Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.
Post : QA - Reviewer / Document Coordinator (Analytical Lab) (8031)
Job Description :
• 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 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 timely manner.
• Any other assignment allocated by reporting manager and/or above.
Qualification : M.Sc. / B.Pharm
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Function Area : Quality Assurance
Req Id : 8031
End Date : 20th February, 2020
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