Quality Assurance Lead

This role is for one of the Weekday's clientsSalary range: Rs 700000 (ie INR 7 LPA)Min Experience: 8 yearsLocation: Chengalpattu, Chennai, KanchipuramJobType: full-timeAs 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.RequirementsKey ResponsibilitiesLead and manage the overall Quality Assurance function, ensuring compliance with cGMP, GDP, and regulatory guidelinesOversee QA processes related to API, pharmaceutical formulations, and pharmaceuticsMonitor and enforce adherence to quality systems, SOPs, and documentation standards across departmentsConduct internal audits, risk assessments, and quality reviews to ensure continuous complianceReview and approve batch manufacturing records, analytical reports, deviations, CAPA, and change controlsSupport regulatory inspections, prepare documentation, and coordinate with cross-functional teams during auditsCollaborate with production and R&D to implement quality improvements, validation protocols, and process optimizationEnsure proper handling, review, and maintenance of electronic QA systems, including those involving Web Services/API integrationsLead investigations into quality incidents, non-conformances, and deviations, ensuring robust CAPA implementationDevelop and mentor QA team members to enhance skill sets and ensure operational efficiencyMaintain strong communication with stakeholders to align quality processes with business goalsSupport vendor qualification, raw material assessment, and supply chain quality requirementsWhat Makes You a Great FitMinimum 8 years of experience in Quality Assurance roles within the pharmaceutical or API industryStrong expertise in pharmaceutical QA, cGMP practices, pharmaceutics, and QA documentation systemsHands-on experience in managing API-related quality processes and handling regulatory auditsKnowledge of Web Services/API workflows related to digital QMS or validation tools is a plusExceptional understanding of QA protocols, compliance requirements, and regulatory expectationsExcellent leadership skills with the ability to guide, mentor, and motivate cross-functional teamsStrong analytical and problem-solving abilities to identify quality risks and implement process improvementsOutstanding communication and documentation skills with a high level of attention to detailAbility to thrive in a fast-paced environment while maintaining accuracy and complianceProactive mindset with ownership, integrity, and a commitment to delivering high-quality outcomes