Quality Assurance Lead

This role is for one of the Weekday's clients

Salary range : Rs 700000 (ie INR 7 LPA)

Min Experience : 8 years

Location : Chengalpattu, Chennai, Kanchipuram

JobType : full-time

As a Quality Assurance Lead, you will be responsible for overseeing all aspects of quality assurance across manufacturing, testing, documentation, and compliance. You will ensure that all API and pharmaceutical processes meet regulatory standards and internal quality benchmarks. Your role will be central to maintaining product integrity, ensuring proper documentation controls, leading audits, and guiding teams through quality-related challenges. You will also collaborate closely with production, R&D, regulatory, and validation teams to build a culture of quality across the organization. A strong understanding of Web Services / API documentation will be an advantage, particularly when working with digital QMS systems or integrated QA workflows.

Requirements

Key Responsibilities

• Lead and manage the overall Quality Assurance function, ensuring compliance with cGMP, GDP, and regulatory guidelines.
• Oversee QA processes related to API, pharmaceutical formulations, and pharmaceutics.
• Monitor and enforce adherence to quality systems, SOPs, and documentation standards across departments.
• Conduct internal audits, risk assessments, and quality reviews to ensure continuous compliance.
• Review and approve batch manufacturing records, analytical reports, deviations, CAPA, and change controls.
• Support regulatory inspections, prepare documentation, and coordinate with cross-functional teams during audits.
• Collaborate with production and R&D to implement quality improvements, validation protocols, and process optimization.
• Ensure proper handling, review, and maintenance of electronic QA systems, including those involving Web Services / API integrations.
• Lead investigations into quality incidents, non-conformances, and deviations, ensuring robust CAPA implementation.
• Develop and mentor QA team members to enhance skill sets and ensure operational efficiency.
• Maintain strong communication with stakeholders to align quality processes with business goals.
• Support vendor qualification, raw material assessment, and supply chain quality requirements.

What Makes You a Great Fit