QMS Project Reviewer Syngene International Limited
Syngene International Limited
Office Location
Full Time
Experience: 3 - 3 years required
Pay:
Salary Information not included
Type: Full Time
Location: Karnataka
Skills: Client handling, Coordination, Communication skills, QMS activities, Project related activities, Master Batch Record Review, Batch Record Review, Analytical Document Review, Good Documentation Practices, Laboratory practices, Specification Review, Method of analysis review
About Syngene International Limited
Job Description
Job Description: As a QMS Project Reviewer at Syngene International Limited in Bengaluru, you will play a vital role in drug substance development and manufacturing processes. Syngene is an innovation-led contract research, development, and manufacturing organization that offers integrated scientific services from early discovery to commercial supply. Safety is a top priority at Syngene, and you will be expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment for yourself, your team, and the lab/plant. Your core responsibilities will include following GMP, GDP, and GLP procedures, creating/revising/reviewing procedures such as SOPs and protocols, reviewing and approving Master BMR and PDR, and ensuring compliance. You will also be responsible for verifying product details, conducting assessments, investigating deviations, and handling returned products and product recalls. This role presents an exciting opportunity to interact with clients globally, collaborate with cross-functional departments, and gain exposure to various aspects of product development and commercial manufacturing. You will be expected to demonstrate expertise in handling QMS activities, reviewing Master Batch Record and Analytical Documents, and maintaining good communication and coordination skills among cross-functional teams. To be successful in this role, you should have 3-6 years of experience in project-related QMS activities, experience in client handling, and a strong educational background with an MSc in Chemistry. Additionally, you should possess good knowledge of Good Documentation and laboratory practices, as well as excellent skills in reviewing specifications and methods of analysis. At Syngene, we value excellence, integrity, and professionalism, and we are committed to providing equal opportunities for all employees. Join us at Syngene and be a part of our mission to deliver high-quality scientific services while maintaining a strong focus on safety and compliance.,