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 Rasayanika.com
Job Title: QA-Reviewer/Document Coordinator(Analytical Lab) (8161)
Work Experience 1-3 years
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.
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