Descrizione del lavoro

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

Executive - Quality Assurance

Where you'll work