Corporate Quality Assurance Executive

Corporate Quality Assurance Executive

Location: Airoli
Experience: 5-8 Years

Role Overview

We are looking for a Quality Assurance professional with experience in pharmaceutical manufacturing to manage quality systems, audits, compliance activities, and contract manufacturing operations. The role requires strong knowledge of cGMP, QMS, and quality assurance practices across OSD and injectable/sterile manufacturing.

Key Responsibilities

• Manage quality activities related to Contract Manufacturing Organizations (CMOs).
• Conduct internal, vendor, and Organisation audits to ensure compliance with regulatory and company standards.
• Handle Change Controls, Deviations, and other Quality Management System (QMS) processes.
• Support vendor qualification and quality management activities.
• Ensure compliance across OSD, sterile, and injectable manufacturing operations.
• Investigate quality issues and drive corrective and preventive actions.
• Support regulatory inspections and customer audits.

Qualifications

• Bachelor's or Master's degree in Pharmacy, Life Sciences, Chemistry, or a related field.
• 5-8 years of Quality Assurance experience in the pharmaceutical industry.
• Strong understanding of CGMP, QMS, Change Control and Vendor Management.
• Experience in OSD and sterile/injectable manufacturing environments.

Key Skills

• Quality Assurance & Compliance
• Audit Management
• Vendor Management
• Quality Systems (QMS)
• Documentation & Regulatory Compliance
• Problem Solving & Root Cause Analysis
• Stakeholder Management

Preferred Candidate: A proactive CQA professional with strong compliance knowledge, audit experience, and the ability to coordinate effectively with internal teams and manufacturing partners.