Executive/Sr.Executive(QA)

MSN Group; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

MSN Group in India is seeking a Quality Assurance professional to manage QA documentation and validation-related activities. The role involves handling change controls, preparing APQR and CPVs, and reviewing validation protocols for processes and cleaning. You will also review batch records and master documents while overseeing stability studies.

The position requires meticulous attention to detail and experience in GMP-compliant environments. The work location is Hyderabad, Telangana.

Qualifications

• Quality Assurance professional with GMP/Pharma domain exposure.
• Experience in reviewing validation and change control documentation.
• Familiarity with APQR, CPV, BPR/BCR/MFR records.

Responsibilities

• Handle change controls and ensure documentation accuracy.
• Prepare and review APQR reports and Continued Process Verifications (CPVs).
• Review and approve validation protocols for processes and cleaning, and monitor activities.
• Review Batch Production Records, Batch Cleaning Records, and Master Formula Records.
• Manage stability studies and quality risk assessments.

Job description

• Handling of change controls.
• Preparation and review of Annual Product Quality Review (APQR) reports and Continued Process Verifications (CPVs).
• Review and approval of process and cleaning validation protocols, including monitoring activities and reviewing validation reports.
• Review of Batch Production Records (BPRs), Batch Cleaning Records (BCRs), and Master Formula Records (MFRs).
• Handling of Quality Risk Assessments.
• Management of stability studies.