Quality Assurance Lead

2 days ago

Chengalpattu, India Weekday AI Full time

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 - Minimum 8 years of experience in Quality Assurance roles within the pharmaceutical or API industry. - Strong expertise in pharmaceutical QA, cGMP practices, pharmaceutics, and QA documentation systems. - Hands-on experience in managing API-related quality processes and handling regulatory audits. - Knowledge of Web Services/API workflows related to digital QMS or validation tools is a plus. - Exceptional understanding of QA protocols, compliance requirements, and regulatory expectations. - Excellent leadership skills with the ability to guide, mentor, and motivate cross-functional teams. - Strong analytical and problem-solving abilities to identify quality risks and implement process improvements. - Outstanding communication and documentation skills with a high level of attention to detail. - Ability to thrive in a fast-paced environment while maintaining accuracy and compliance. - Proactive mindset with ownership, integrity, and a commitment to delivering high-quality outcomes.

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