Executive - Quality Assurance

TITLE: Executive - Quality Assurance

DESCRIPTION:

Role Overview

This position is for a Quality Assurance professional to support GMP compliance across manufacturing and warehouse operations in Pune/Pimpri-Chinchwad. The role focuses on documentation review, validation oversight, investigation support, and quality system upkeep in line with regulatory expectations and approved procedures.

Key Duties

• Carry out site visits to DS manufacturing and warehouse facilities to confirm that operations are aligned with GMP standards, regulatory needs, and approved procedures.
• Take part in manufacturing investigations and help close CAPA actions.
• Draft and review risk assessments along with mitigation plans.
• Monitor process validation and cleaning validation work to ensure execution matches approved protocols.
• Examine core master documents such as study protocols, BPRs, and MFRs.
• Check executed Batch Processing Records to support batch release decisions.
• Review Batch Dispatch Records and confirm warehouse dispatch activities.
• Coordinate the collection and compilation of APQR data and support preparation of the APQR.
• Prepare and review SOPs and other quality system documents.
• Review departmental SOPs to verify GMP compliance across functions.

Experience Required

The role calls for 3 to 5 years of relevant experience.

Education Required

Candidates should have a Master’s degree in Biotechnology, or a postgraduate qualification in Pharmacy or Pharmaceutical Technology.

Competencies

• Innovation and creative thinking
• Customer focus
• Talent development mindset
• Results-driven approach