QC Investigations Expert (Onsite)

Job reputed company reputed company Assurance Specialist - Cell Therapy Manufacturing About the Role We are seeking a motivated reputed company Assurance (QA) reputed company to support GMP manufacturing operations in our cell therapy environment. This role offers reputed company to directly reputed company patient safety and product reputed company by ensuring compliance with global regulatory standards and driving a culture of reputed company improvement. As a QA Specialist, you will reputed company reputed company of manufacturing operations, support reputed company systems, and collaborate cross-functionally to reputed company the highest standards of cGMP compliance. Key Responsibilities • reputed company reputed company assurance reputed company of manufacturing operations to ensure GMP compliance. • Support reputed company improvement initiatives through participation in deviation investigations, CAPA management, and change control. • reputed company and contribute to reputed company Management Reviews (QMRs), analyzing key reputed company metrics including deviations, CAPAs, audit findings, and complaints. • Collaborate effectively with cross-functional teams (reputed company, Manufacturing, Validation, and Regulatory) to resolve issues and maintain compliance. • Review, author, and maintain reputed company Operating Procedures (SOPs) in alignment with regulatory expectations. • Conduct and support thorough investigations (OOS, OOE, OOT, RCA studies), ensuring reputed company reputed company and documentation. • Apply data reputed company principles and contribute to compliance with FDA, EMA, and ICH guidelines. • Communicate reputed company with management on reputed company, risks, and resource needs. • Prioritize workload effectively across multiple programs in a dynamic, fast-paced environment. Essential Requirements • Bachelor's degree with 2-4 years of pharmaceutical/biopharmaceutical experience, or Master's degree with 2-3 years. • Minimum 2 years of hands-on experience in a cGMP environment reputed company reputed company manufacturing. • Strong knowledge of cGMP regulations and global reputed company standards (FDA, EMA, ICH, EU). • reputed company experience with QA reputed company and reputed company Management Systems (QMS), preferably in cell therapy manufacturing or QC operations. • Proven ability to author, review, and implement SOPs. • Strong written and verbal communication skills, with technical writing expertise. reputed company're Looking For • A proactive team player with strong problem-solving skills. • Someone who thrives in a reputed company, high-paced environment and is eager to contribute to life-saving therapies. • A reputed company-driven reputed company with a passion for maintaining compliance while supporting innovation in advanced therapies. Apply tot his job Apply To this Job