AQA Reviewer

Designation:

Job Location:

Department:

About Syngene

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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 speci fi cation.


• 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 Quali

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:

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:

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