Aqa Reviewer

Designation AQA Reviewer Job Location Bangalore Department Analytical Quality Assurance About Syngene Incorporated in 1993 Syngene International Ltd is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK Merck KGaA and Herbalife Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems improve R D productivity speed up time to market and lower the cost of innovation Key Responsibilities Review of analytical raw data through ELN manual generated by analyst protocols reports pertaining to the section as per the standard operating procedure and specification Ensuring verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP Review of Outsourced analytical report Review of logbooks with respect to all activity performed in the lab Responsible for taking any other job allocated by Department Head Department In charge Review of technical data in analytical document viz Calculations Chromatograms method parameters integration logbook entries WS RS and Column usage records method parameters reconciliation vendor COA and other technical data in analytical document Responsible to ensure review and release of raw material and packing material in LIMS SAP Responsible to ensure review and release of cleaning samples inprocess samples calibration reports and standard qualification reports Reviewer shall ensure the documents physically for availability of all the pages of ODS and supporting documents Review the documents for completeness compliance to good documentation practices test results against specification limits or acceptance criteria as mentioned in protocol and reconciliation of forms issued as applicable Review of all the tests as specified in the specification Request for analysis validation protocol sampling protocol have been carried out Review of all supporting documents like chromatograms balance print outs Instrument printouts are enclosed in sequential manner to the parent report with signature as applicable Review of the test results in COA against specification along with other relevant sample information before approval In case of any discrepancy immediately notify to the reporting manager or his designee or Head or designee GMP Analytical Laboratory Ensuring of conducting regular GMP rounds at Quality Control Laboratory Involving in the Laboratory incident investigation review and approval Educational Qualification M Sc Life science Chemistry M Pharm Technical functional Skills Good exposure in Enterprise Applications like SAP Learning Management Systems Trackwise and Analytical laboratory Applications like Chromatography and Non-chromatography data Management Well versed in electronic data audit review Good Knowledge on handling the application software Establish good Interpersonal skills with cross-functional teams Experience 9 to 12 Years experience in life science industry Behavioural Skills Strong commitment towards work and a high level of dedication enthusiasm motivation and persuasive ability in a team Good speaking-listening-writing skills attention to details proactive self-starter Ability to work successfully in a dynamic ambiguous environment Ability to meet tight deadlines and prioritize workloads Ability to develop new ideas and creative solutions Should be able to work in team and flexible for working in shifts Should be a focused employee Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities