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
Qualification
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.
Editor’s Note: Syngene QA Reviewer Job Subscribe to Rasayanika for latest chemistry and Pharma job openings, follow us on Facebook and Whatsapp and subscribe to our youtube channel for latest updates on chemistry and Pharma jobs and much more.
