Syngene Careers: Development Quality Assurance Specialist | Apply Now Pharma Jobs in Bangalore
Syngene Careers offers an excellent opportunity for experienced professionals through this Development Quality Assurance Specialist role, one of the most sought-after Pharma Jobs in Bangalore. This position at Syngene focuses on quality systems, formulation development, regulatory compliance, and safety practices within an innovation-led CRO environment.
Job Details
- Job Title: Specialist, Development Quality Assurance
- Job Location: Bengaluru, India
About the Company
Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene Careers, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit, making it a trusted name among Pharma Jobs in Bangalore.
Job Description
This role under Syngene Careers is responsible for the Quality Systems of Development Services and relevant QA activities. The position collaborates actively with operational units of development services to improve alignment and achieve customer satisfaction and value realization, strengthening Syngene’s leadership in Pharma Jobs in Bangalore.
Key Responsibilities
- Responsible for driving the Phase Gate for Product Development across Formulation Development functions
- Review and approval of formulation development reports, QbD reports, risk assessment reports, hold time study reports, and related documents
- Review and assess the risk associated with the process and the mitigation plan
- Review and provide inputs on analytical methods for robustness
- Review and approval of formulation technology transfer from Development Services to Manufacturing
- Review and approval of method transfer documents and specifications for early and late phase programs
- Review and approval of transfer protocols and reports
- Coordination with cross-functional teams to complete assigned work on time and data review
- Review scientific experiments as per project requirements in formulation development laboratories
- Perform root cause analysis and why-why analysis
- Review of Quality Assurance procedures in EDMS
- Review and implementation of cross-deployment of CAPAs across Development OUs
- Support customer audits and handle customer queries related to quality and compliance
- Ensure compliance with Syngene quality standards and data integrity policies
- Drive EHS mindset and operational discipline
- Ensure completion of mandatory training related to data integrity, health, and safety
Qualifications
- Master’s degree in Pharmacy, Master’s in Chemistry, or Life Sciences (preferred)
- Ph.D. in Pharmacy, Chemistry, or Life Sciences (preferred)
- Proven track record of successfully managing responsibilities
- Sound knowledge of formulation development techniques
- Sound knowledge of guidelines such as ICH, USP, etc.
- Strong understanding of regulatory requirements
- Excellent communication, interpersonal, and problem-solving skills
- Ability to work effectively with cross-functional teams and OUs
Skills and Capabilities
- Exposure to Drug Development and Commercial
- Technology Knowhow
- Compliance Management
- Process Excellence
- Execution Focus
- Accountability
- Collaboration
Syngene Values
- Excellence
- Integrity
- Professionalism
