About the Role

• We are looking for a detail-oriented and experienced Senior Executive – Quality Assurance to oversee and improve all Quality Management System (QMS), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) activities within a leading pharmaceutical manufacturing environment.

Key Responsibilities

• Ensure manufacturing operations comply with cGMP and GLP standards.
• Handle QMS functions including change control, validations, stability studies, qualifications, APQR, and risk assessments.
• Coordinate applications and documentation for regulatory bodies (AHC, AQCS, EIA, Capexil).
• Conduct and manage internal and external audits (ISO, FDA, GMP+, etc.), and maintain audit documentation.
• Evaluate and approve suppliers and service providers for raw materials, packaging materials, and testing labs.
• Assist in customer complaint analysis and prepare related reports.
• Investigate deviations, OOS, and incidents, ensuring effective corrective and preventive actions.
• Review and maintain Batch Manufacturing Records (BMR) and guide process improvements.
• Review and manage label artwork and ensure regulatory compliance.

Required Competencies

Technical Skills

• Strong analytical and problem-solving abilities.
• Proficiency in QA documentation and report writing.
• In-depth understanding of GMP, GDP, and quality systems.
• Excellent written and verbal English communication skills.

Behavioral Skills

• Strong quality and service orientation.
• Proven ability to prioritize, organize, and deliver results under deadlines.
• Team-oriented with cross-functional collaboration skills.
• Customer-centric approach with attention to detail.

Benefits

• Opportunity to work in a globally compliant manufacturing setup.
• Exposure to niche pharmaceutical products and international quality standards.
• Supportive company culture with focus on employee growth and recognition.
• Medical insurance coverage for immediate family.
• Subsidized bachelor or family accommodation (for outstation candidates).
• Five-day working week (alternate weeks).