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 Solid 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 .
