Senior Associate, Quality Assurance

Sansphere Pharma; Chennai; On-site; INR 800,000 - 1,500,000; Full time

Job summary

SanSphere Pharma is seeking an experienced QA professional to strengthen its Quality Management System. You will own SOP development, vendor qualification and day-to-day QA activities, ensuring operations remain compliant with cGMP and global regulatory expectations.

Key responsibilities include drafting and controlling SOPs, conducting vendor audits, handling CAPA and deviations, reviewing BMR/BPR, supporting regulatory submissions and inspections, and training staff on GMP practices.

Qualifications

• Experience in SOP development and control
• Familiarity with cGMP and global regulatory expectations

Responsibilities

• Draft, review, revise and control SOPs, work instructions, formats and quality policies
• Plan and carry out vendor/supplier qualification: questionnaires, audits (on-site/remote), risk assessments, quality agreements and periodic re-evaluation
• Maintain the Approved Vendor List and track how vendors perform
• Handle change controls, deviations, CAPA, OOS/OOT investigations and market complaints
• Review batch manufacturing and packaging records (BMR/BPR), specifications and analytical documents
• Support the review of regulatory documentation for ANDA/DMF submissions
• Prepare for and support regulatory inspections (USFDA, EU, WHO-GMP, CDSCO) and customer audits
• Run internal audits and self-inspections, and track the findings until they are closed
• Support Annual Product Quality Reviews (APQR), qualification/validation activities and data integrity compliance
• Train staff on SOPs and GMP practices

Job description

About Us

SanSphere Pharma is a growing pharmaceutical company focused on generic (ANDA) product development and partnerships with companies around the world. Were a small, close-knit team where every member has real ownership and a direct impact on quality and compliance.

Role Overview

We are looking for an experienced QA professional to strengthen our Quality Management System. You will own SOP development, vendor qualification and day-to-day QA activities, and you will make sure our operations stay compliant with cGMP and global regulatory expectations.

Key Responsibilities

• Draft, review, revise and control SOPs, work instructions, formats and quality policies
• Plan and carry out vendor/supplier qualification: questionnaires, audits (on-site/remote), risk assessments, quality agreements and periodic re-evaluation
• Maintain the Approved Vendor List and track how vendors perform
• Handle change controls, deviations, CAPA, OOS/OOT investigations and market complaints
• Review batch manufacturing and packaging records (BMR/BPR), specifications and analytical documents
• Support the review of regulatory documentation for ANDA/DMF submissions
• Prepare for and support regulatory inspections (USFDA, EU, WHO-GMP, CDSCO) and customer audits
• Run internal audits and self-inspections, and track the findings until they are closed
• Support Annual Product Quality Reviews (APQR), qualification/validation activities and data integrity compliance
• Train staff on SOPs and GMP practices