Quality Assurance Manager

Role & Responsibilities Summary:

This role involves leading the Quality function, including Quality Assurance (QA), Quality Control (QC), and Microbiology departments, ensuring compliance with international regulations and maintaining high-quality standards. The individual will oversee manufacturing operations, product quality, audits, and continuous improvement initiatives.

Key Responsibilities:

• Leadership & Quality Culture: Lead and mentor the Quality function, ensuring audit readiness and fostering a quality-driven culture.
• Regulatory Compliance & Audits: Ensure compliance with regulatory. WHO GHP, Revised Schedule M and successful audit outcomes.
• Manufacturing Operations: Oversee cGMP-compliant operations and production of OSD, SVP (General and Beta Lactam), External Preparations including scale-up and new product development
• SOPs & Documentation: Ensure SOPs align with WHO GHP, Revised Schedule M regulations and collaborate on new product registrations.
• QMS & Continuous Improvement: Strengthen QMS systems, drive improvements, and ensure quality compliance across the organization.
• Risk Management & Compliance: Conduct regular compliance reviews, ensure facility/equipment qualification, and manage quality risk assessments.
• Dossier Filing for Exports.

Key Skills & Experience:

• Extensive experience in regulated manufacturing environments, especially for injectable products.
• Strong audit and compliance management experience, with leadership capabilities

Preferred candidate profile

• Bachelors degree in Pharmacy/ Science or related field.
• Quality Assurance Post Graduation Qualification Preferred
• Ability to effectively communicate verbally and in writing.
• Ability to effectively work with teams.
• Strong analytical and negotiation skills.
• Open to travel (50% time) and manage various scheduling requirements.

Role: QA Manager

Industry Type: Pharmaceutical & Life Sciences

Department: Quality Assurance

Employment Type: Full Time, Permanent

Role Category: Production & Manufacturing

Experience: 15-25 Years