Senior Quality Assurance Executive

1 week ago

Vadodara, Gujarat, India Exemed Full time ₹ 9,00,000 - ₹ 12,00,000 per year
  • 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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