Quality Assurance Executive

Company Description About Tulsi Therapeutics: A pioneering biotechnology venture dedicated to advancing regenerative cellular therapies through rigorous research, precision manufacturing, and global distribution of next-generation stem cell and exosome-based treatments. Our mission is to address some of the world's most challenging and life-threatening medical conditions—particularly those with limited or ineffective therapeutic options—by delivering innovative solutions that restore hope and improve patient outcomes. We aim to develop a "Made in India" therapeutic solution that is globally competitive in quality and affordability, positioning India as a hub for advanced cell therapy solutions. Our Mission & Vision: We are committed to Democratizing Stem Cell Therapy by transcending socio-economic barriers and bringing hope and effective treatment options to patients worldwide. We strive for Excellence in Manufacturing for Maximum Clinical Impact, ensuring the highest quality and ethical production of stem cells and exosomes, thereby setting new benchmarks in regenerative medicine. Role Description This is a full-time on-site role for a Quality Assurance Executive with a background in life sciences to support our QA operations at Hyderabad. The ideal candidate will have 2-3 years of QMS experience and a keen eye for detail, ensuring compliance with industry regulations and company SOPs. Key Responsibilities: - Document Control & SOP Management: Draft, update, review and maintain Standard Operating Procedures (SOPs), work instructions, and other quality documents. Assist in distributing and archiving controlled documents to ensure compliance and easy retrieval. - Batch Record Review: Examine batch production and testing records for accuracy and completeness. Flag and help resolve discrepancies or deviations before product release. - Deviation & CAPA Support: Assist in documenting, investigating, and tracking deviations, non-conformances, and complaints. Support the implementation and follow-up of Corrective and Preventive Actions (CAPA). - Internal Audits & Inspections: Help prepare for audits by gathering necessary documentation, coordinating schedules, and supporting the audit process. Participate in internal audits as required. - Quality Control Testing Support: Liaise between the QA and QC teams. Ensure that QC data is complete, accurate, and available to QA for review. - Training Coordination: Maintain training records related to quality procedures. Ensure employees are up to date on required training programs and SOPs. - GMP/GLP Compliance Monitoring: Monitor operations for compliance with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and company policies. Identify and report any compliance gaps. - Change Control & Risk Assessment: Assist in change control activities, including evaluating proposed changes, updating documentation, and performing basic risk assessments. - Supplier & Material QA: Support qualification, monitoring, and evaluation of suppliers and raw materials, including maintaining approved supplier lists and documentation. - Continuous Improvement Support: Gather metrics on quality trends, assist with process improvement projects, and participate in cross-functional teams to implement quality enhancements. - Routine Quality Checks: Perform or assist with routine in-process and final product inspections to monitor compliance and product quality standards. Qualifications - Education: Bachelor's or Master's in Life Sciences (Pharmacy, Microbiology, Biotechnology, Biochemistry, etc.) - 2-3 years of QA QMS experience in a life-sciences or pharmaceutical industry - Good knowledge and understanding of quality control and quality assurance activities, GMP, and regulatory standards - Strong attention to detail and ability to uphold stringent quality standards - Excellent documentation, communication and teamwork abilities - Excellent problem-solving and analytical skills What We Offer: - A collaborative and innovation-driven work culture - Opportunities for professional growth and skill development - Exposure to cutting-edge lab practices and technologies - Competitive compensation and benefits Why Join Us? - Be part of a mission-driven biotech company at the cutting edge of regenerative medicine. - Contribute to groundbreaking therapies with global impact. - Work in a collaborative, innovative environment that values scientific excellence. - Opportunity to grow with a high-potential biotech company backed by government support and global expertise.