Quality Design Assurance

Role & responsibilities Position: Quality Assurance (QA) Executive

Department: Quality Assurance (QA)

Education:

B.Pharm / M.Pharm

Experience:

Freshers with relevant pharmaceutical qualifications may be considered for trainee roles

Key Responsibilities

Perform in-process quality assurance (IPQA) checks during manufacturing and packaging activities.

Conduct line clearance activities and ensure compliance with approved procedures.

Review and approve Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), SOPs, protocols, and reports.

Handle deviations, incidents, Change Controls, CAPA, OOS (Out of Specification), and OOT (Out of Trend) investigations.

Ensure compliance with cGMP, GDP, GLP, and regulatory requirements.

Monitor validation and qualification activities, including equipment qualification (DQ, IQ, OQ, PQ).

Participate in internal audits, customer audits, and regulatory inspections.

Review and maintain quality documentation and data integrity records.

Coordinate with Production, Quality Control, Engineering, and Regulatory Affairs teams to resolve quality issues.

Conduct GMP training and support continuous quality improvement initiatives.

Support Annual Product Quality Review (APQR/PQR) activities and risk management programs.

Ensure timely implementation and effectiveness of corrective and preventive actions (CAPA).

Preferred candidate profile