Syngene Careers: Quality Assurance Specialist | MSc Chemistry Graduates Apply Now
Are you looking for Quality Assurance Specialist roles, MSc Chemistry jobs, or exciting growth opportunities with Syngene careers? This Development Quality Assurance Specialist position in Bengaluru offers an exciting opportunity to work across formulation development, quality systems, and regulatory compliance. The role plays a critical part in ensuring safe operations, robust quality governance, and successful technology transfer within Syngene’s discovery and development ecosystem.
About Syngene
Syngene is an innovation-led contract research, development, and manufacturing organization (CRDMO) providing integrated scientific services from early discovery to commercial supply. Syngene Careers offers exciting opportunities for professionals across research, development, and quality functions, including Quality Assurance Specialist roles. With a strong commitment to safety, data integrity, and regulatory compliance, Syngene maintains world-class quality systems and operational excellence. The organization works closely with global pharmaceutical and biotechnology partners, making it an ideal workplace for candidates seeking MSc Chemistry jobs and advanced careers in drug development, formulation, and quality assurance within a collaborative, science-driven environment.
- Job Title: Development Quality Assurance Specialist
- Location: Bangalore, KA, IN, 560099
Profile Description:
This role will be responsible for crafting the allocation methodologies and process flows for Development services. This
individual will collaborate actively with the Operation Units of development services to improve alignment and achievement of customer satisfaction and value realization.Core Purpose of the Role:
Responsible for Quality Systems of Development Services and relevant QA activities.
Role Accountabilities
- 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 other documents generated for formulation development projects.
- Review and assess the risk associated with the process and the Mitigation Plan.
- Review and provide inputs on analytical methods to have robust methods.
- Review and approval of Formulation Technology Transfer from Development Services to Manufacturing.
- Review and approval of Method transfer documents and Specifications for all early and late phase programs.
- Review and approval of formulation development reports and QbD reports during development.
- Review and approval of transfer protocols & reports.
- Coordination with cross-functional teams to complete the assigned work on time and data review.
- Responsible for reviewing scientific experiments as per project requirements in a process development laboratory catering to formulation development.
- Providing the exact root cause for the issues and performing a why-why analysis to understand the challenges.
- Review of Quality Assurance procedures in EDMS.
- Contributing to development procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
- Providing the exact root cause for the issues and performing a why-why analysis to understand the challenges.
- Review and implementation of cross-deployment of CAPAs across Development OUs.
- Support for facing Customer audits and their related compliance.
- Support for handling customer queries related to quality & compliance with Development OUs.
- Overall adherence to safe practices and procedures of oneself and the teams is aligned.
- Driving a corporate culture that promotes an EHS mindset and operational discipline at the workplace.
- Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always in the workplace.
- Ensure all assigned mandatory training related to data integrity, health, and safety measures is completed on time by all members of the team, including oneself.
- Compliance with Syngene quality standards and Data integrity policies always.
- Hold self-accountable for the achievement of safety goals.
Requirements
- Master’s degree in Pharmacy, Master’s in chemistry/life sciences, both are preferable.
- Proven track record of successfully managing and leading respective time.
- 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.
- Technology Transfer development to manufacturing.
- Knowledge to set acceptance criteria for process validation and transfers, handle technology transfer, and data review as part of the transfer.
