Job Summary:

•    Determine whether quality activities and related QC-QA audits and processes comply with the cGMP requirement.
•    Review of all the raw data including chromatograms and certificate of analysis generated during various testing in Quality control lab such as Raw material testing, packaging material testing, in-process testing, stability testing, equipment cleaning samples testing, Process validation samples analytical method validation/verification testing, etc.
•    Review of protocols, raw data, and Reports related to instrument calibration and qualification.
•    Review of raw data and Reports related to working standard qualification.
•    Review the audit trails and ensure proper integration on Empower software as a basis of soft version review prior to the release of any certificate of analysis.
•    Release of all the data on the SAP system and performing user decisions were ever required (example raw material/packaging material).
•    Review of Deviation and out of specification related raw data and respective reports
•    Review of daily calibrations like an oven, balance, pH meter, etc.
•    Issuance of quality documents like Protocols, certificate of analysis, Laboratory Notebooks etc to QC.
•    Performing Sample log in for all samples that are received in QC for testing.
•    Preserving all the quality document related to testing and submitting to QA department for Archival as a part of document control.
•    Provide support for Operations, Regulatory affairs, R & D and Quality Control objectives.
•    Review of data and report related to Analytical method validation as required.
Reporting Relationships    
•    This will be more of individual contributor and working in a team of QA auditors responsible for review of analytical data generated in QC department and releasing of the material and reporting to Sr. Manager QA.

Essential Functions:

•    The person will record the analytical package received from QC for auditing
•    The person will review the raw data received including not limited to data package, lab note book, protocol pages etc from QC related to testing and calibration.
•    He will review the data with respect to the standard operating procedure and quality control methods.
•    He will suggest correction and will ensure that the corrections are made prior to release of the material.
•    Once raw data is audited, he will review the accompanying COA and will sign off the COA, if required.
•    He will evaluate the results (perform 2 to 5) in SAP and then will give UD as required.
•    They will collect and store the raw data (folders and lab notebook) and will submit to QA for archival.
•    Incase if there is Lab event, deviation or out of specification, They will review all data generated as a part of investigation.
•    The person will review the investigation report to ensure that there are no transcription errors in They report and will sign-off the report.
•    The person will perform periodic audit trial review and will generate the report.
•     The person will assist the department will upgrading / creating new SOPs as required.
•    The person will assist the department by providing the requested data / document and by participation in any type of audit (internal and/or external) . 

Specialized Skills and Knowledge:    

•    A bachelor’s degree with chemistry/pharmacy as major is required at a minimum.
•    Knowledge of handling HPLC and Empower chromatographic Software and minimum 3 years of experience in auditing of QC documents
•    Knowledge of other QC testing.
•    Knowledge of current cGMP Guidelines as needed for effective function of role.
•    Reviewing and Auditing Skills.
•    Basic knowledge of working on computers.
•    Knowledge of various pharmacopeia

Key Competencies:

1.    Effective Communication (Written and Verbal).
2.    Analytical and Problem solving ability.
3.    Document / Report drafting.