QA Executive/ QA Manager

Role Overview:

The Quality Assurance personnel will be responsible for leading and overseeing all QA operations to ensure that Neo India Lifelines products meet the highest quality, regulatory, and compliance standards. The role involves developing & managing the Quality Management System, driving continuous improvement, ensuring GMP compliance, and maintaining effective collaboration among internal teams and external partners.

Key Responsibilities:

• Lead and enhance the organizations Quality Management System (QMS) to ensure robust regulatory and corporate compliance.
• Provide strategic oversight on QA processes including documentation control, deviations, CAPA, and change management.
• Supervise QA activities across manufacturing, packaging, and analytical operations to uphold cGMP standards.
• Plan and coordinate internal audits and ensure preparedness for regulatory and partner inspections.
• Lead the review, negotiation, and execution of Quality Technical Agreements (QTAs) with CMOs, partners, and vendors.
• Oversee supplier qualification, audits, and quality risk assessments ensuring compliance with approved standards.
• Approve and monitor SOPs, specifications, and product quality documentation in line with global requirements.
• Ensure accuracy and compliance of artwork, labelling, and product lifecycle records.
• Present QA performance insights, compliance metrics, and risk mitigation plans to senior management.

Qualifications & Experience:

• Bachelors or Master’s degree in Pharmacy, Life Sciences, or related discipline.
• 4-5 years of experience in QA (for Executive) within the pharmaceutical or healthcare industry.
• In-depth knowledge of Global Regulatory guidelines.
• Experience in handling Quality Agreements, QTAs, and CMO oversight is essential.
• 7-8 years of experience in QA (for Manager) within the pharmaceutical industry.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication, leadership, and team management abilities.