AQA - Executive

Exemed; Padra; On-site; INR 600,000 - 900,000; Full time

Job summary

Exemed in Padra, Gujarat, India, seeks a QA/QC professional to oversee validation reviews, incident closures, OOS/OOC processes, and stability data review for API release. The role ensures compliant QC and Microbiology labs, data integrity, and audit readiness.

The incumbent will train on cGMP/GLP and handle QMS documents, process approvals, and internal/external audits, contributing to continuous quality improvement.

Responsibilities

• Responsible to review Analytical method validation, Analytical method transfer protocol and reports. To ensure that all the instruments used for analysis are in calibrated state.
• Responsible for reviewed incident and closure.
• Responsible for login of OOS, OOT & OOC and review 1st phase investigation.
• Responsible for review stability analysis data and preparation stability analysis summary report.
• To review completed ATDS & Laboratory control records before release of the API for distribution.
• Responsible to review audit trial of the QC, Microbiology Lab instrument and to ensure appropriate method utilized during analysis of the material.
• To handling of QMS documents. i.e. Deviation, Market Complain, OOS, OOT, Incident & CAPA.
• To ensure cGMP compliance in Quality Control & Microbiology Laboratory.
• To review Batch Manufacturing, Equipment Cleaning and relevant records.
• Responsible to approve or reject intermediate/second crop.
• Responsible to review audit trial of the QC & Microbiology Lab instrument and to ensure appropriate method utilized during analysis of the material.
• Responsible to review of data in the chromatographic and non-chromatographic system.
• Responsible to ensure that all materials are appropriately tested and the results are reported.
• Responsible to impart training on cGMP, GLP and other trainings as required.
• Approval for Re-integration authorization in absence of approved authorizes.
• COA Approval for immediate action in absence of approved authorizes.
• To perform internal audit (Self inspection) /external audits and provide compliance report for internal/external audits.
• Responsible to carry out other activities as instructed by Head-QA.
• Responsible to approve, release or reject of intermediate, bulk and finished product.
• Responsible for review of QC ,Microbiology Instruments/Equipments qualification and CSV.

Job description

Job Responsibility:

• Responsible to review Analytical method validation, Analytical method transfer protocol and reports. To ensure that all the instruments used for analysis are in calibrated state.
• Responsible for reviewed incident and closure.
• Responsible for login of OOS, OOT & OOC and review 1st phase investigation.
• Responsible for review stability analysis data and preparation stability analysis summary report.
• To review completed ATDS & Laboratory control records before release of the API for distribution.
• Responsible to review audit trial of the QC, Microbiology Lab instrument and to ensure appropriate method utilized during analysis of the material.
• To handling of QMS documents. i.e. Deviation, Market Complain, OOS, OOT, Incident & CAPA.
• To ensure cGMP compliance in Quality Control & Microbiology Laboratory.
• To review Batch Manufacturing, Equipment Cleaning and relevant records.
• Responsible to approve or reject intermediate/second crop.
• Responsible to review audit trial of the QC & Microbiology Lab instrument and to ensure appropriate method utilized during analysis of the material.
• Responsible to review of data in the chromatographic and non-chromatographic system.
• Responsible to ensure that all materials are appropriately tested and the results are reported.
• Responsible to impart training on cGMP, GLP and other trainings as required.
• Approval for Re-integration authorization in absence of approved authorizes.
• COA Approval for immediate action in absence of approved authorizes.
• To perform internal audit (Self inspection) /external audits and provide compliance report for internal/external audits.

• Responsible to carry out other activities as instructed by Head-QA.
• Responsible to approve, release or reject of intermediate, bulk and finished product.
• Responsible for review of QC ,Microbiology Instruments/Equipments qualification and CSV.