Syngene International Ltd
Designation : Manager
Function : Quality Assurance
Functional Area : Design QA
Job Role Summary : Manage research and development quality assurance division, Responsible for Quality Systems of Development Services and relevant QA activities
Job Profile :
- Lead Quality Management System activities at Syngene.
- Liaise with Global Quality to align on quality principles and process flow for discovery and development projects at BRDS.
- Execute quality risk assessment across different development stages of Biologics Discovery and
- Development and implement phase appropriate QMS principles.
- Ensure that OOS, Deviations, Customer Complaints are investigated, reviewed and CAPA implemented in accordance with QMS requirements. Ensure change controls are assessed.
- Coordinating with Cross functional team other GxP functions for the implementation of Quality Management System (QMS).
- Training of employees on QMS procedures.
- Prepare / Review of documentation such as Quality Manual, Site Master Files, SOPs and Quality Agreements.
- Planning and follow-up of QMS activities for closure within the target timeline for Biologics Operation Units.
- Preparation of QMS Metrics within BRDS.
- Preparation and review of risk assessment for Quality activities.
- Preparation and review of trends as per schedule for all QMS elements as applicable.
- Liaise with and support the Internal Audit and Continuous Improvement team for the timely closure of the CAPA.
- Facilitate continuous improvement via QMS to improve the health of the Quality Systems.
- Participate and coordinate the client and regulatory audits for Biologics Discovery and Development Labs.
- Accountable for reviewing and approving protocols, SOPs, IOPs and documents related development, method qualification, Specifications, Tech-Transfer, etc.
- Responsible for approval and timely availability of Technology Transfer from Development services to Manufacturing services; Analytical Method and Process Development Transfer documents.
- Develop role-based training modules for BRDS and ensure training of staff on quality procedures, processes, policies and issue training binders.
- Implement phase appropriate quality procedures and DI related training across operating units.
- Implementation of role-based curricula in Discovery and Development Services and ensure compliance.
- Approve annual training planner, instrument audit trail and eLN audit trail schedules.
- Execute root cause investigation by performing why-why analysis and propose mitigation strategies and implement CAPAs.
- Responsible for facing audits by clients and regulatory bodies.
- Lead regular meetings with team members to communicate operational information and objectives.
Job Requirements :
- Experience in driving quality assurance in pharmaceutical/biopharmaceutical industry
- Proven track record in implementing QMS in biologics development.
- Strong understanding of biologics development process flow including early-stage process development, scale-up and technology transfer.
- Good knowledge of international quality guidelines applied for biologics drug development including ICHQ, USP, etc.
- Knowledge of electronic notebooks and should be well versed in TrackWise QMS Software for raising Deviation, Change Control and CAPA.
- Excellent interpersonal communications with track record of working in dynamic environment
Type of Experience : Pharma Biologics QA, DQA experience
Academic Qualifications :
- Masters or Doctorate degree in Pharmaceuticals, Biotechnology, Engineering or any stream of Science.
