• 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.
• 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.
• 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
1. Effective Communication (Written and Verbal).
2. Analytical and Problem solving ability.
3. Document / Report drafting.
Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.
|Job Category||Quality Assurance|