Quality Assurance Specialist Job at Syngene Careers | Life Sciences Jobs
If you are an experienced Quality Assurance Specialist aiming to work at the forefront of pharmaceutical innovation, this opportunity at Syngene Careers is designed for you. This role offers one of the most impactful Life Science Jobs, focusing on development quality systems, formulation development oversight, regulatory compliance, and safety excellence within a globally respected organization.
- Job Title: Development Quality Assurance Specialist
- Location: Bangalore, KA, IN, 560099
- Division: Essential Functions
- Department: Discovery and Development QA
About the Company:
Syngene International Ltd. is an innovation-led Contract Research, Development, and Manufacturing Organization (CRDMO) offering integrated scientific services from early discovery to commercial supply. At Syngene, safety, integrity, and quality are embedded into every process, making Syngene Careers a trusted destination for professionals in life science and pharmaceutical domains.
Job Overview:
The Quality Assurance Specialist will be responsible for managing quality systems for Development Services and executing QA activities across formulation development projects. The role involves reviewing scientific documentation, driving phase-gate reviews, ensuring data integrity, supporting audits, and maintaining compliance with global regulatory standards while fostering a strong EHS culture.
Key Responsibilities:
- Drive phase-gate processes for product and formulation development
- Review and approve formulation development, QbD, risk assessment, and hold-time study reports
- Assess process risks and evaluate mitigation plans
- Review analytical methods to ensure robustness
- Approve formulation and method technology transfer documents
- Coordinate with cross-functional development teams for timely execution
- Review QA procedures within EDMS
- Implement CAPAs and support cross-deployment across development units
- Support customer audits and quality-related queries
- Ensure continuous compliance with safety, data integrity, and quality standards
Educational Requirements:
- Master’s degree in Life Sciences (preferred)
- Ph.D. in relevant disciplines is an added advantage
Skills Required:
- Strong knowledge of formulation development techniques
- Expertise in ICH, USP, and regulatory guidelines
- Experience in technology transfer from development to manufacturing
- Sound understanding of data integrity and compliance systems
- Excellent communication, problem-solving, and collaboration skills
- Ability to lead QA initiatives in cross-functional environments
This Quality Assurance Specialist role at Syngene Careers is a powerful opportunity for professionals seeking advanced Life Science Jobs that combine scientific depth, regulatory excellence, and career growth. Join Syngene to contribute to impactful drug development while upholding world-class quality standards.
