Job
Description
Job Summary As a qualified candidate, you will be leading the Quality Assurance, QC Chemistry and Microbiology Laboratories for the site. Your role will involve developing Standard Operating Procedures (SOPs), ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory guidelines, and monitoring day-to-day department activities. Responsibilities include reviewing and approving documents, executing in-process controls, participating in investigations, vendor qualification, stability management, and ensuring safety practices. Roles & Responsibilities You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories. You will ensure adherence to systems and procedures by all QA and laboratory personnel. You will be responsible for organizing contract laboratory audits and certification. You will formulate systems and procedures for the effective implementation of cGMP, GLP (Good Laboratory Practices), and other industry practices and regulations for the manufacture, storage, and distribution of drug products. You will plan and monitor the daily activities of different sections of the department, ensuring the availability of required facilities and materials for daily functions. You will ensure timely review and approval of all Master documents, such as SOPs, guidelines, production records, specifications, validation protocols, and other necessary reports/documents. You will be responsible for proper sampling of in-process and finished products, management of reserve and stability samples, and collection of finished products. You will oversee the execution of in-process controls and checks during manufacturing and packing. Your role includes reviewing and releasing/rejecting finished drug product batches, evaluating product recalls, monitoring quantity and disposition of recalled/returned material. You will participate in investigations, providing suitable Corrective and Preventive Actions (CAPA) to prevent recurrence. You will review, approve, and implement CAPA for incidents, change controls, Out of Specifications (OOS) and Out of Trends (OOT) observations. You will manage vendor qualification, material management, vendor audits, stability management, and field alerts as required. As a qualified trainer, you will implement training programs, ensure compliance, and provide training on cGMP and SOPs. You will ensure compliance with CAPA for deficiencies noted in self-inspections, internal audits, and external audits. Your responsibilities include preparing and approving Annual Product Quality Reviews, reporting Adverse Drug Reactions, and ensuring departmental adherence to safety practices. You will also be responsible for ensuring the safety, strength, purity, and efficacy of the product, along with any other assignments from higher management. Qualifications Educational qualification: An M. Pharm/M.Sc. with experience in Sterile products. Minimum work experience: 15 to 20 years. Skills & Attributes Technical Skills Experience in recruitment and training of QA and laboratory personnel in Chemistry and Microbiology laboratories. Experience in establishing systems and procedures for cGMP, GLP, and other industry practices. Experience in handling investigations, audits, and implementing resulting CAPAs. Skills in vendor qualification, audits, and material management. Behavioural Skills Effective leadership and organizational skills for managing laboratory personnel and operations. Detail-oriented mindset for thorough review and approval processes. Strong communication and collaboration skills for audits, investigations, and compliance activities. Commitment to safety practices and reporting Adverse Drug Reactions. Additional Information About the Department Global Manufacturing Organisation (GMO) Dr. Reddy's Laboratories is dedicated to making an impact on global healthcare through precision manufacturing and innovation. With 19 state-of-the-art manufacturing plants across multiple locations, we are a leading force in the pharmaceutical industry. Our capability to deliver quality medicines to patients in 66 countries is driven by benchmarking manufacturing processes and operational excellence. Benefits Offered At Dr. Reddy's, we prioritize your career growth and professional development through personalized learning programs. Our benefits are designed to meet industry standards, including joining & relocation support, family benefits, learning opportunities, medical coverage, and life coverage. Our Work Culture At Dr. Reddy's, our employees are guided by the principle of "Good Health Can't Wait." We see healthcare solutions as a means to help patients lead healthier lives. Our work culture fosters empathy, dynamism, and teamwork, empowering individuals to make a meaningful impact on global healthcare. Visit our career website at [Dr. Reddy's Careers](https://careers.drreddys.com/#!/) for more details.,
