Senior Quality Assurance Executive

Exemed

7 - 10 years

6 - 9 Lacs

vadodara

Posted:1 hour ago| Platform:

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Skills Required

change control oos qms quality management quality assurance capa market complaints sop oot deviation apqr

Work Mode

Work from Office

Job Type

Full Time

Job Description

To ensure the GMP and GLP compliances.
To participate in OOS, OOT, Deviation and complaint investigation, root cause analysis and to review investigation report. To carry out closure activities.
To compile data provided by manufacturing, warehouse, QC for preparation of complaint investigation report.
To prepare and review trends of OOS, OOT, Deviation, complaints, customer audit/inspection.
To initiate change controls pertaining to QA and to review change controls of other departments w.r.t impacted activities. To review change control trend.
To compile data for and prepare, review risk assessment reports w.r.t. Deviation, OOS, OOT, Nitrosamine impurities, elemental impurities, etc.
To approve SOP preparation request, print request, training tasks, document publish request of all departments in Caliber Software. To review SOPs of all departments in Caliber software.
To approve specification, STP and TDS preparation request, training tasks, document publish request of all QC department in Caliber Software.
To assist conduction of customer audits and regulatory inspections.
To verify the audit/inspection preparedness.
To compile data and prepare the customer audit/ regulatory inspection compliance report.
To convey the audit observation and activities planned for compliance along with TCD to respective departments.
To perform internal audits of departments as per schedule.
To compile data and prepare QRM report, presentation. To prepare minutes of meeting of QRM and convey the action plan with all departments.
To prepare LOA and LOC as per requirement of customer and to assist in market response and queries.
To evaluate change controls w.r.t regulatory impact.
To compile data for DMF preparation of US, EP and ROW grade.
To review protocols and reports of process validation, cleaning validation, general study, etc.
To review vendor questionnaires.

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